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 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 there was a black spec in the syringe.

Manufacturer Narrative

The reported event was inconclusive due to a poor sample condition.It was unknown if the device met specifications.The product was intended to be used for treatment purposes.It is unknown whether the product caused the reported failure.Visual evaluation of the returned sample noted four opened (without original packaging), unused irrigation bulb syringes.It was noted that one of the syringes was only partially visible in the photo sample.Visual inspection of the photo sample noted small streaks of foreign material between the bulb and barrel on two syringes.A dark, round speck was visible between the bulb and barrel on a third syringe.Without the physical sample to evaluate, it could not be determined whether the foreign material was within specification or not.A potential root cause for the reported failure could be, ¿no follow up to the production areas cleaning procedure.¿ the device history record was reviewed and found nothing that could have caused or contributed to the reported event.Sec.801.116 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.

Event Description

It was reported that there was a black spec in the 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: 9310200
• MDR Text Key: 173790253
• Report Number: 1018233-2019-07244
• 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,user facility
• Type of Report: Initial,Followup
• Report Date: 03/24/2020

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: NGDU0310
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2019
• Initial Date Manufacturer Received: 10/21/2019
• Initial Date FDA Received: 11/12/2019
• Supplement Dates Manufacturer Received: 03/19/2020
• Supplement Dates FDA Received: 03/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1