MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BULB TYPE IRRIGATION SYRINGE 50ML, PLASTIC STERILE

Model Number 0035280

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

Patient Problem No Patient Involvement (2645)

Event Date 09/17/2020

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 a hair was found in the device.

Manufacturer Narrative

The reported event was confirmed, as supplier related.Visual inspection noted one bulb irrigation syringe was received with the original package.Visual evaluation noted a long black hair-like fragment measuring 0.0910" was found in between the syringe body and the bulb.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 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 a hair was found in the device.

• Brand Name: BULB TYPE IRRIGATION SYRINGE 50ML, PLASTIC STERILE
• Type of Device: IRRIGATION SYRINGE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 10711105
• MDR Text Key: 212292420
• Report Number: 1018233-2020-20262
• Device Sequence Number: 1
• Product Code: KYZ
• UDI-Device Identifier: 00801741049255
• UDI-Public: (01)00801741049255
• 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: 0035280
• Device Catalogue Number: 0035280
• Device Lot Number: NGEN1981
• 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