MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 CLOSED WOUND SUCTION

Catalog Number	0071200
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2024
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.Udi format updated with available product information per gudid.
Event or Problem Description
It was reported that a hair was found inside the packaging of the suction evacuator prior to opening it in the operating room to drain waste fluid.
Additional Manufacturer Narrative
The reported event was confirmed cause unknown.Received (3) photo samples.The first photo sample shows the overview of the silicone closed wound suction evacuator.The second photo shows the strand of hair inside the open packaging.The third photo shows the product packaging information.Visual evaluation of the returned sample noted one opened (with original packaging), silicone closed wound suction evacuator.Visual inspection of the sample noted a strand of hair inside the open packaging on the evacuator.This does not meet specification which states no hair is permitted on the product.No actions can be taken at this time since a root cause was not identified.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.The instructions for use were found adequate and state the following: indications for use: wound drains are used to remove exudates from wound sites.Note: not made with natural rubber latex.A.Drain placement for 100 cc, 200 cc, and 400 cc silicone evacuators 1.Place wound drain(s) within critical fluid collection areas.2.Draw non-perforated section of wound drain through skin until drain indicator mark appears at the skin surface.3.Attach non-perforated section of drain directly to evacuator inlet port.4.200 cc and 400 cc silicone evacuators: when using 2 silicone drains with one evacuator, clip sealed inlet port and attach second drain.B.Drain placement for all other evacuators 1.Place wound drain(s) within critical fluid collection areas.2.Draw non-perforated section of wound drain through skin until drain indicator mark appears at the skin surface.3.Attach non-perforated section of drain either to y-connector or directly to evacuator inlet port.4.With two silicone drains, attach blue adaptors to drains and y-connector, and attach y-connector to inlet port.Precautions: avoid suturing through the drain.Drain 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.Drain should be checked during closure for free motion to avoid possibility of breakage.Drain removal should be done gently by hand.It should not be handled with pointed, tooth or blunt instruments which could cause cuts or nicks and lead to subsequent structural failure of the drain.Warnings: drain breakage may require surgical removal.After use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable local, state and federal laws and regulations.Correction: d, h udi format updated with available product information per gudid.H11: section a through f - the information provided by bd represents all 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 a hair was found inside the packaging of the suction evacuator prior to opening it in the operating room to drain waste fluid.

• Brand Name: CLOSED WOUND SUCTION
• Common Device Name: WOUND SUCTION
• Manufacturer (Section D): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer (Section G): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 20256032
• Report Number: 1018233-2024-05853
• Device Sequence Number: 7979872
• Product Code: GCY
• UDI-Device Identifier: 00801741049637
• UDI-Public: (01)00801741049637(11)240222(17)281231(10)NGJN1396
• 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: Other,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2024

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 Catalogue Number: 0071200
• Device Lot Number: NGJN1396
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2024
• Supplement Date Received by Manufacturer: 11/18/2024
• Initial Report FDA Received Date: 09/19/2024
• Supplement Report FDA Received Date: 11/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown