MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 RELIAVAC CLOSED WOUND SUCTION SYSTEM WITH HUBLESS SILICONE FLAT DRAIN, X-RAY OPA

Catalog Number	0070370
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/24/2019
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 a foreign material was found before use.Per additional information from the ibc via email 14jan2020, there appeared to be a white piece of foreign material adhered to the inlet tube.
Event or Problem Description
It was reported that a foreign material was found before use.Per additional information from the ibc via email 14jan2020, there appeared to be a white piece of foreign material adhered to the inlet tube.
Additional Manufacturer Narrative
The reported event was confirmed.Visual evaluation of the returned sample noted one opened (inside original packaging), hubless flat silicone channel drain.Visual inspection of the sample noted a white plastic piece of material (measuring greater than 5.00 sq mm) on the clear tubing of the drain.This was out of specification, which states, "no foreign loose / embedded matter in an excess of 0.6mm2 or1/16" length." although the reported event was confirmed, the root cause could not be determined.A potential root cause for this failure could be, ¿no follow up to production areas cleaning procedure.¿ 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: ¿important a.Check for fluid entering reliavac® evacuator.Lack of flow may indicate: - all exudate has been removed.- wound drain is clogged and may require irrigation and aspiration (consult physician).- auxiliary wall suction pressure is above 210mm hg.- deflated balloon: check all connections for air leak and wound tube perforations for exposure above the skin.If still deflated, replace evacuator.B.When not using auxiliary suction during surgical wound closure, several activations of the reliavac® evacuator may be required to establish suction because of: - air entering partially closed wound.- an operative air pocket.C.Insert safety pin into hole in collar to attach evacuator to patient's clothing or bed linen.Caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.To avoid the possibility of a hematoma due to wound evacuation, the instructions for use should be carefully followed.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 during closure for free motion to avoid 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.Warning: surgical removal may be necessary if drain is difficult to remove or breaks." 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.

• Brand Name: RELIAVAC CLOSED WOUND SUCTION SYSTEM WITH HUBLESS SILICONE FLAT DRAIN, X-RAY OPA
• Common Device Name: SILICONE FLAT DRAIN
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9643144
• Report Number: 1018233-2020-00592
• Device Sequence Number: 16926400
• Product Code: GBX
• UDI-Device Identifier: 00801741090745
• UDI-Public: (01)00801741090745
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2020

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: 02/29/2024
• Device Catalogue Number: 0070370
• Device Lot Number: NGDP3997
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2020
• Initial Date Received by Manufacturer: 01/07/2020
• Supplement Date Received by Manufacturer: 02/26/2020
• Initial Report FDA Received Date: 01/29/2020
• Supplement Report FDA Received Date: 03/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1