MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 PENROSE DRAIN

Catalog Number	0912010
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
Event or Problem Description
It was reported that there was unknown debris inside the sealed packaging prior to use.
Additional Manufacturer Narrative
The reported event was confirmed as manufacturing related due to foreign material being sealed within closed packaging.A penrose drain was returned unopened in it its original packaging.Foreign material was noted inside of the packaging.Material contained a length of 0.13 inches and a width of 0.0575 inches.This is out of specification.Although the reported event was confirmed, the root cause could not be determined.A potential root cause for this failure could be defective/ contaminated components from the supplier.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: ¿warnings: to avoid the possibility of drain damage or breakage: ¿ avoid suturing through drains as this may result in breakage during removal or undesired leakage.¿ drains should lie flat and in line with the skin exit areas.¿ particular care should be taken to avoid any obstacles to the drain exit path.¿ drains should be checked for free motion during closure to minimize the possibility of breakage.¿ drain removal should be done gently by hand.Drains should not be handled with pointed, toothed or sharp instruments which could cause cuts or nicks and lead to subsequent structural failure of the drain; and ¿ surgical removal may be necessary if drain is difficult to remove or breaks.Drain placement ¿ the surgeon should irrigate the wound with sterile fluid, then suction the irrigating fluid and gross debris from the operative site.¿ tubes should lie flat and in line with the anticipated skin exit.¿ to facilitate later removal by manual traction, the tubing should not be curled, pinched, or sutured internally.Positioning of the drain in the body cavity, as well as the number of drains indicated, should be determined by the operating surgeon.¿ drain tubing should be placed within areas of critical fluid collection.¿ care must be taken to ensure that all drain perforations or channels lie completely within the wound or cavity to be drained.¿ taping or a triple loop suture (around and not through the tubing) will aid in preventing accidental drain displacement.¿ care must be exercised to avoid damage to the drain (see warnings).¿ the tubing should be repeatedly checked during closure for free motion to avoid fluid retention, breakage and/or fragment retention within the wound." h11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
It was reported that there was unknown debris inside the sealed packaging prior to use.

• Brand Name: PENROSE DRAIN
• Common Device Name: PENROSE DRAIN
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8758126
• Report Number: 1018233-2019-03604
• Device Sequence Number: 16564144
• Product Code: GBX
• UDI-Device Identifier: 00801741051234
• UDI-Public: (01)00801741051234
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2020
• Device Catalogue Number: 0912010
• Device Lot Number: NGCU3056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2019
• Initial Date Received by Manufacturer: 06/12/2019
• Supplement Date Received by Manufacturer: 07/25/2019
• Initial Report FDA Received Date: 07/03/2019
• Supplement Report FDA Received Date: 08/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1