MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 PVC DRAIN WITH TROCAR, MEDIUM 1/8", 10 FR. (3.2MM) OD, 12.5" (31.7CM) HOLE PATTE; WOUND DRAIN

Catalog Number	0080710
Health Effect - Clinical Codes	No Patient Involvement (2645); 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.The information provided by bard 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 bard.
Event or Problem Description
It was reported that there was a foreign item in the tubing of the wound drain.
Event or Problem Description
It was reported that there was a foreign item in the tubing of the wound drain.
Additional Manufacturer Narrative
The reported event was confirmed.Visual evaluation of the returned sample noted one unopened (sealed original packaging present), unused wound drain product present.After removing the sample from both sealed packages it was contained in, a small 0.3285" in length brown spot was visible on the surface of the tubing.The material appeared to be over-cured or burnt pvc, as the surrounding tubing exhibited a puckered appearance, indicative of plasticizer migration.This embedded foreign material was greater than the acceptable limits, therefore the tubing was considered out of specification.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: ¿pvc round drains instructions for use indications: wound drains are used to remove exudates from wound sites.Warning: when placing drain(s), care should be taken to ensure that the perforate portion of the wound drain lies completely within the confines of the wound.Read product insert provided with the closed wound evacuator for detailed instructions, warnings, and precautions associated with the use of the evacuator device.To avoid the possibility of drain damage or breakage: ¿ additional perforations should not be made in the drains.¿ avoid suturing through drains.¿ drains should lie flat and in like 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.They should not be handled with pointed, toothed, or sharp instruments which could cause cuts or nick and lead to subsequent structural failure of the drain.¿ surgical removal may be necessary if the drain is difficult to remove or breaks.Drain placement using a pvc drain 1.Draw drain using trocar from outside into inside of wound then from inside to outside of wound on other side.2.Cut wound tube in the middle of the perforated section.3.Remove trocar only by cutting the drain tubing one inch from end of trocar.4.Trim non-perforated section of drain to desired length.5.Attach drains to individual evacuators or to y connector 0070770.6.Insert connecting tube into evacuator.¿ correction: mfr site.

• Brand Name: PVC DRAIN WITH TROCAR, MEDIUM 1/8", 10 FR. (3.2MM) OD, 12.5" (31.7CM) HOLE PATTE
• Common Device Name: WOUND DRAIN
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7654909
• Report Number: 1018233-2018-02534
• Device Sequence Number: 19424368
• Product Code: GBX
• UDI-Device Identifier: 00801741050121
• UDI-Public: (01)00801741050121
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other,user facili
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2018

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: Lay User/Patient
• Device Expiration Date: 03/31/2023
• Device Catalogue Number: 0080710
• Device Lot Number: NGCQ2828
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2018
• Initial Date Received by Manufacturer: 06/14/2018
• Supplement Date Received by Manufacturer: 09/10/2018
• Initial Report FDA Received Date: 07/02/2018
• Supplement Report FDA Received Date: 09/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1