MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 SILICONE FLAT DRAIN; WOUND DRAIN

Catalog Number	0070360
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	01/23/2024
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.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 hair mixed in sterile bag of wound drain device.Per internal comments received on (b)(6) 2024, it was confirmed that it was unopened.They confirmed that there was a foreign object in the sterilized bag.Inside the bag containing the product.
Additional Manufacturer Narrative
The reported event is confirmed manufacturing related.Visual evaluation noted received 1 hubless silicone flat drain.Visual inspection of the sample noted a strand of hair inside the packaging.Also received 4 photo samples.First photo sample shows top view of hubless silicone flat drain enclosed within original packaging and red arrow indicating towards hair strand.Second photo sample showing top overview of outer packaging.Third photo sample shows end of catheter.Fourth photo sample zooms in on hair strand within closed packaging.Based on photo and original sample received the product does not meet specifications which states "no hair is permitted on the product." although a root cause could not be definitively identified, based on the risk documentation review, a potential root cause for this type of failure could be packaging is not stable over the shelf life of the device.However, there was insufficient information to confirm this potential root cause.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.Labelling review is not required as labelling would not have prevented the reported event.Correction: d,h.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 hair mixed in sterile bag of wound drain device.Per internal comments received on 30jan2024, it was confirmed that it was unopened.They confirmed that there was a foreign object in the sterilized bag.Inside the bag containing the product.

• Brand Name: SILICONE FLAT DRAIN
• Common Device Name: WOUND DRAIN
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 18702179
• Report Number: 1018233-2024-00697
• Device Sequence Number: 17690860
• Product Code: GBX
• UDI-Device Identifier: 00801741090738
• UDI-Public: (01)00801741090738
• 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): 05/20/2024

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: 0070360
• Device Lot Number: NGHN2722
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2024
• Supplement Date Received by Manufacturer: 05/20/2024
• Initial Report FDA Received Date: 02/14/2024
• Supplement Report FDA Received Date: 05/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/31/2023
• 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