MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 DAVOL SILICONE ROUND SINGLE DRAIN, 10"; WOUND DRAIN

Catalog Number	0070330
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/30/2019
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 the user found a foreign material inside the package prior to opening it.
Additional Manufacturer Narrative
The reported issue was confirmed.The device was returned for evaluation.Visual inspection of the returned sample noted one unopened (inside original packaging), silicone round wound drain.Visual inspection of the sample noted 2 black pieces of foreign material (measuring 0.40 sq mm and 0.20 sq mm; 0.60 sq mm total) loose inside the outer packaging.This was out of specification, which stated, "no loose or embedded foreign matter not to exceed 1/32¿ in length or 0.4mm² per tappi dirt estimation chart/ruler." although the reported event was confirmed, the root cause could not be determined.A potential root cause for this failure could be, ¿omitted washing operation.¿ 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: ¿indications: wound drains are used to remove exudates from wound sites.Warning: when placing drain(s) care should be taken to ensure that the perforated 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 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.They 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.¿ surgical removal may be necessary if drain is difficult to remove or breaks.Drain placement a.Using a single silicone drain 1.Place perforated wound drain within critical fluid collection area of wound.2.Draw non-perforated section of wound drain through to the outside until drain indicator mark appears at the skin surface.Two sets of indicator marks aid placement of the drain.3.Trim non-perforated section of drain to desired length.4.Insert connecting tube of drain to drain port of evacuator.B.Using two silicone drains 1.Repeat steps 1-3 above.2.Attach proximal ends of silicone drains to the bard® y-connector (#0070790) and connect y-connector to evacuator drain port.C.Using a silicone double 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 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 0070780 or 0070790.6.Insert other blue adapter into y-connector and attach drains to each blue adapter.7.Insert connecting tube into evacuator." 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 the user found a foreign material inside the package prior to opening it.

• Brand Name: DAVOL SILICONE ROUND SINGLE DRAIN, 10"
• Common Device Name: WOUND DRAIN
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9443900
• Report Number: 1018233-2019-07841
• Device Sequence Number: 380325
• Product Code: GBX
• UDI-Device Identifier: 00801741049484
• UDI-Public: (01)00801741049484
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2020

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: 01/31/2024
• Device Catalogue Number: 0070330
• Device Lot Number: NGDN0093
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2019
• Initial Date Received by Manufacturer: 11/18/2019
• Supplement Date Received by Manufacturer: 01/15/2020
• Initial Report FDA Received Date: 12/10/2019
• Supplement Report FDA Received Date: 01/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1