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

Catalog Number 0935280

Device Problems Contamination /Decontamination Problem (2895); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

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 hair was found in the bulb while the syringe was still in the package.The issue was noted prior to use.

Event Description

It was reported that hair was found in the bulb while the syringe was still in the package.The issue was noted prior to use.

Manufacturer Narrative

The reported event could not be confirmed.A potential failure mode could be ¿product with foreign material / hair; loose or embedded¿ with a potential root cause of ¿defective / contaminated components from supplier¿.The device was not returned for evaluation.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.¿medical devices having commonly known directions: a device shall be exempt from section 502(f)(1) of the act insofar as adequate directions for common uses thereof are known to the ordinary individual."" product catalog number 0935280 is deemed by appropriate subject matter experts (sme) to be within this definition." 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.

• Brand Name: SYRINGE IRRIGATION BULK / CLEAN, 50ML
• Type of Device: BULB SYRINGE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9954582
• MDR Text Key: 187906467
• Report Number: 1018233-2020-02549
• 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: 04/24/2020

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 Catalogue Number: 0935280
• Device Lot Number: NGDU1778
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/24/2020
• Initial Date FDA Received: 04/13/2020
• Supplement Dates Manufacturer Received: 04/20/2020
• Supplement Dates FDA Received: 04/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1