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

Model Number	0070370
Medical Device Problem Code	Wrong Label (4073)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, that the barcode for single units of silicone drain was the barcode for a box of 10 units.As per the additional information received on 30 may 2023, the customer stated, that the distributor when read the bar code of the product which was single unit.The data of a box of 10 units were displayed.In other words, the complaint, was that the bar code on the product was wrongly attached.
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.
Additional Manufacturer Narrative
The reported event was unconfirmed because the reported failure could not be reproduced.The device met relevant specifications.Visual evaluation of the returned sample noted six unopened (with original packaging), hubless silicone flat drain.Visual inspection of the sample noted that the gtin code 00801741090745 that is used in label pk7644433 is for 1 (one) unit of 0070370 and found to be adequate.A dhr review is not required as the event is unconfirmed.As the reported event is unconfirmed a labeling review is not required.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.H3 other text : the actual/suspected device was inspected.
Event or Problem Description
It was reported that the barcode for single units of silicone drain was the barcode for a box of (b)(4) units.As per the additional information received on 30may2023, the customer stated that the distributor when read the bar code of the product which was single unit, the data of a box of (b)(4) units were displayed.In other words, the complaint was that the bar code on the product was wrongly attached.

• 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 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: 17117105
• Report Number: 1018233-2023-04272
• Device Sequence Number: 6574601
• 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: Other,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2023

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 Model Number: 0070370
• Device Catalogue Number: 0070370
• Device Lot Number: NGGW1247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2023
• Supplement Date Received by Manufacturer: 07/12/2023
• Initial Report FDA Received Date: 06/13/2023
• Supplement Report FDA Received Date: 07/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2022
• 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