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

Catalog Number 0935280

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

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

Event Date 10/16/2019

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 or a piece of fiber was found in the syringe.

Event Description

It was reported that hair or a piece of fiber was found in the syringe.

Manufacturer Narrative

The reported event was confirmed.Visual inspection noted one bulb syringe was received.Visual evaluation noted a piece of hair measuring 0.2730" embedded in the shaft of the syringe.This is out of specification per inspection procedure which states, "loose or embedded foreign matter greater than 0.6mm2 or 1/16¿ in length is not permitted.(3 particles maximum per side or surface).Per tappi dirt estimation chart." although the reported event was confirmed, the root cause could not be determined.A potential root cause for this failure could be, ¿no follow up to the production areas cleaning procedure.¿ the lot number is unknown; therefore, the device history record could not be reviewed.A labeling review was not performed because the user alleged the presence of foreign material on the product, which the user did not cause.Labeling does not apply in this case.

• 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: 9343906
• MDR Text Key: 179760019
• Report Number: 1018233-2019-07409
• 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: 12/09/2019

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 Catalogue Number: 0935280
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2019
• Initial Date Manufacturer Received: 10/29/2019
• Initial Date FDA Received: 11/19/2019
• Supplement Dates Manufacturer Received: 12/06/2019
• Supplement Dates FDA Received: 12/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1