FDA Adverse Event Injury Summary report: N

ON-Q PUMP

MDR report key: 2434296 · Received January 27, 2012

Report

Report Number: 2026095-2012-00006
Event Type: Injury
Date Received: January 27, 2012
Date of Event: November 18, 2004
Report Date: January 10, 2012
Manufacturer: I-FLOW CORP.
Product Code: MEB
PMA / PMN Number: K063530
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: IL, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

METHOD: NO PRODUCT WAS RETURNED FOR EVALUATION AND INVESTIGATION. THE LOT NUMBER WAS NOT PROVIDED, THEREFORE THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. RESULTS: THE INFORMATION CONTAINED IS FROM LEGAL DOCUMENTS SERVED ON I-FLOW CORPORATION. THE COMPLAINT WAS OPENED SO THAT A MEDICAL DEVICE REPORT (MDR) CAN BE FILED WITH THE US FOOD AND DRUG ADMINISTRATION. NO FURTHER INVESTIGATION WILL BE CONDUCTED. THE ON-Q PUMP DIRECTIONS FOR USE (DFU) CONTAIN A WARNING THAT STATES: "AVOID PLACING THE CATHETER IN JOINT SPACES. ALTHOUGH THERE IS NO DEFINITIVE ESTABLISHED CAUSAL RELATIONSHIP, SOME LITERATURE HAS SHOWN A POSSIBLE ASSOCIATION BETWEEN CONTINUOUS INTRA-ARTICULAR INFUSIONS (PARTICULARLY WITH BUPIVACAINE) AND THE SUBSEQUENT DEVELOPMENT OF CHONDROLYSIS." (DFU 1307011). I-FLOW HAS ALSO PREPARED A TECHNICAL BULLETIN ENTITLED "WHAT WE KNOW ABOUT CHONDROLYSIS TODAY." (1303722, REV. E). CONCLUSION: AS THIS COMPLAINT WAS CREATED FROM A LAWSUIT SERVED ON I-FLOW, NO CUSTOMER CONTACT CAN BE MADE AT THIS TIME DUE TO THE PENDING LITIGATION.

Description of Event or Problem · 1

DRUG/DILUENT: UNKNOWN. FILL VOLUME: UNKNOWN. FLOW RATE: UNKNOWN, PROCEDURE: ARTHROSCOPIC RIGHT SHOULDER. CATHPLACE: UNKNOWN. PATIENT ALLEGES CHONDROLYSIS FOLLOWING PLACEMENT OF AN I-FLOW INFUSION PUMP AFTER SURGERY ON (B)(6) 2004.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ON-Q PUMP	ELASTOMERIC PUMP	MEB	I-FLOW CORP.	UNKNOWN	UNKNOWN

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other