MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 SYRINGE IRRIGATION BULK / CLEAN, 50ML; IRRIGATION SYRINGE

Catalog Number 0935280

Device Problems Contamination (1120); Device Contamination with Chemical or Other Material (2944)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

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 hair was found inside the bulb syringe.

Manufacturer Narrative

The reported event was confirmed.Visual evaluation of the sample noted one irrigation bulb syringe without original packaging.It was noted that there was a hair within the syringe barrel.No hair is permitted on the product.Although the reported event was confirmed, the root cause could not be determined.A potential root cause for this failure could be defective / contaminated components from supplier.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.A labeling review was not performed because the user could not have caused the reported issue so labeling does not apply.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.

Event Description

It was reported that hair was found inside the bulb syringe.

• Brand Name: SYRINGE IRRIGATION BULK / CLEAN, 50ML
• Type of Device: IRRIGATION SYRINGE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9491662
• MDR Text Key: 179260271
• Report Number: 1018233-2019-08067
• Device Sequence Number: 1
• Product Code: KYZ
• UDI-Device Identifier: 10801741051378
• UDI-Public: (01)10801741051378
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 01/30/2020

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 Expiration Date: 12/31/2023
• Device Catalogue Number: 0935280
• Device Lot Number: NGCZ2768
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2019
• Initial Date Manufacturer Received: 11/26/2019
• Initial Date FDA Received: 12/18/2019
• Supplement Dates Manufacturer Received: 01/23/2020
• Supplement Dates FDA Received: 01/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1