MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 CLOSED WOUND SUCTION 100ML SILICONE EVACUATOR; WOUND DRAIN

Catalog Number 0071440

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/16/2019

Event Type  Injury  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported the drain broke apart when the physician attempted removal, leaving a piece embedded in the patient.The drain was put in place on (b)(6) 2019 and the removal attempt on (b)(6) 2019.The retained portion was removed via surgery the next day on (b)(6) 2019.

Event Description

It was reported the drain broke apart when the physician attempted removal, leaving a piece embedded in the patient.The drain was put in place on (b)(6) 2019 and the removal attempt on (b)(6) 2019.The retained portion was removed via surgery the next day on (b)(6) 2019.

Manufacturer Narrative

The reported event was confirmed.Visual evaluation of the returned sample noted one opened (without original packaging), used (note tissue and organic detritus present in tubing and evacuator) hubless flat silicone wound drain and silicone bulb evacuator.Visual inspection of the sample noted that the wound drain tubing was torn, unevenly and completely through, near the flat drain juncture.This is out of spec per inspection procedure, which states that the inspector is to "visually inspect for: rough surfaces, jagged end cuts, kinks, tears and surfaces free from blemishes, grease" in the wound drain tubing.Although the reported event was confirmed, the root cause could not be determined.A potential root cause for this failure could be "insufficient time or temperature to cure the drain." 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 closed wound suction evacuator.Lack of flow may indicate all exudate has been removed.Check all connections for air leaks and wound tube perforations for exposure above skin.B.Several activations of the closed wound suction evacuator may be required to establish suction because of: air entering partially closed wound.An operative air pocket.C.The attached strap may be used to secure the evacuator to the patient.Precautions: 1.Avoid suturing through the drains to minimize the possibility of breakage.2.Drains should lie flat and in line with the skin exit path.3.Particular care should be taken to avoid any obstacles to the drain exit path.4.Drains should be checked for free motion during closure to minimize the possibility of breakage during/after removal.5.Drain removal should be done gently by hand.Drains should not be handled with pointed, toothed or blunt instruments which could cause cuts or nicks and lead to subsequent structural failure of the drain.Warning: drain breakage may require surgical removal.100cc silicone closed wound suction evacuator and silicone drains indications for use: wound drains are used to remove exudates from wound sites." 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: CLOSED WOUND SUCTION 100ML SILICONE EVACUATOR
• Type of Device: WOUND DRAIN
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8794658
• MDR Text Key: 151205386
• Report Number: 1018233-2019-03948
• Device Sequence Number: 1
• Product Code: GCY
• UDI-Device Identifier: 00801741049675
• UDI-Public: (01)00801741049675
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 08/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0071440
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2019
• Initial Date Manufacturer Received: 06/24/2019
• Initial Date FDA Received: 07/16/2019
• Supplement Dates Manufacturer Received: 07/17/2019
• Supplement Dates FDA Received: 08/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 86 YR
• Patient Weight: 62