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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: I-FLOW CORP. ON-Q PAIN PUMP WITH CATHETER ELASTOMERIC PUMP

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I-FLOW CORP. ON-Q PAIN PUMP WITH CATHETER ELASTOMERIC PUMP Back to Search Results
Event Date 03/03/2006
Event Type  Injury  
Event Description

Drug/diluent: unknown. Fill volume: unknown. Flow rate: unknown. Procedure: right shoulder arthroscopic surgery. Cathplace: glenohumeral joint. Reference: 2026095-2012-00064 ((b)(4)). During removal, the catheter broke leaving a portion of the catheter in the right glenohumeral joint. Pt underwent surgery on (b)(6), 2006, to remove the remaining catheter.

 
Manufacturer Narrative

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. 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. As of (b)(4) 2006 i-flow has updated its on-q pump directions for use (dfu), to include the following in the warnings section: "avoid placing the catheter in joint spaces. Although there is no definitive established causal relationship, some literature has shown a possible association between continous intra-articular infusions (particularly with bupivacaine) and the subsequent development of chondrolysis. " (dfu 1307011). On (b)(4) 2007, i-flow has also prepared a technical bulletin entitled "what we know about chondrolysis today". (1303722, rev. E). The directions for use (dfu) (1307112, rev. A) provide cautions and directions on catheter removal if resistance is encountered. It also contains a caution of "do not cut or forcefully remove catheter. " i-flow has also prepared a technical bulletin (1303971, rev. B) in order to prevent or decrease catheter breaks entitled: "tips for preventing in-situ catheter breakage with the on-q post-op pain relief system. " it is not worth noting that i-flow's catheters are made of a non-toxic, medical-grade material that meets (b)(4) tissue compatibility guidelines for implantation of up to 30-days; complications may arise if a catheter (or portion thereof) is left in the body for longer than this period of time.

 
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Brand NameON-Q PAIN PUMP WITH CATHETER
Type of DeviceELASTOMERIC PUMP
Manufacturer (Section D)
I-FLOW CORP.
lake forest CA
Manufacturer Contact
maria wagner, sr. specialist
20202 windrow dr.
lake forest , CA 92630
9495973957
MDR Report Key2555836
Report Number2026095-2012-00065
Device Sequence Number1
Product CodeMEB
Report Source Manufacturer
Source Type Other
Reporter Occupation
Type of Report Initial
Report Date 04/05/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/27/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received04/05/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 04/27/2012 Patient Sequence Number: 1
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