MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 EAR/ULCER SYRINGE, PVC-FLEX 3 OZ. (GREEN), STERILE; EAR AND ULCER SYRINGE

Model Number 0035820

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 09/08/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that foreign material was found in device.

Manufacturer Narrative

The reported event was confirmed, as a manufacturing-related.Visual evaluation of the returned sample noted two unopened (inside original packaging), ear and ulcer syringes were received.Visual inspection of the sample noted two pieces of cardboard-like paper material (measuring 1.80 sq mm and 1.50 sq mm) loose on the syringes inside the package.Also, a black foreign material was much larger than 0.6 mm was found in the package.Although the reported event was confirmed, the root cause could not be determined.A potential root cause for this failure mode could be due to a "defective/ contaminated components from the supplier." the devices did not meet the specifications, and was influenced by the reported failure.The product used for the treatment purposes.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The labeling review was not performed because the labeling could not have prevented the reported failure.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.H3 other text : the actual/suspected device was inspected.

Event Description

It was reported that the foreign material was found in device.

• Brand Name: EAR/ULCER SYRINGE, PVC-FLEX 3 OZ. (GREEN), STERILE
• Type of Device: EAR AND ULCER SYRINGE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 10712537
• MDR Text Key: 212334497
• Report Number: 1018233-2020-20272
• Device Sequence Number: 1
• Product Code: KYZ
• UDI-Device Identifier: 00801741049279
• UDI-Public: (01)00801741049279
• 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: 01/20/2021

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
• Device Operator: Health Professional
• Device Model Number: 0035820
• Device Catalogue Number: 0035820
• Device Lot Number: NGDZ0702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2020
• Initial Date Manufacturer Received: 09/23/2020
• Initial Date FDA Received: 10/21/2020
• Supplement Dates Manufacturer Received: 01/20/2021
• Supplement Dates FDA Received: 02/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other