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

Model Number 0935280

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

Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/21/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.

Event Description

It was reported that there was a black hair found inside the bulb syringe.

Event Description

It was reported that there was a black hair found inside the bulb syringe.

Manufacturer Narrative

The reported event was inconclusive as no sample returned for evaluation.A potential root cause for this failure mode could be due to a defective or contaminated components from the supplier.It was unknown whether the device had met relevant specifications.The product was intended to be used for treatment purposes but it was unknown whether the product had caused the reported failure.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 due to the labelling could not have prevented the reported failure.Correction: f, 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 device was not returned.

• 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 30014
• MDR Report Key: 12170403
• MDR Text Key: 261708573
• Report Number: 1018233-2021-04215
• 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: other
• Type of Report: Initial,Followup
• Report Date: 09/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0935280
• Device Catalogue Number: 0935280
• Device Lot Number: NGEY0583
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other