MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 SYRINGE IRRIGATION BULK

Catalog Number 0935280

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

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

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 unknown hair from an unknown source was found inside the pack.A new set-up needed to be obtained by the team.The pack had to be discarded and the room had to be shut down and the surgery needed to be rescheduled since the room was contaminated with the hair in the package.

Event Description

It was reported that unknown hair from an unknown source was found inside the pack.A new set-up needed to be obtained by the team.The pack had to be discarded and the room had to be shut down and the surgery needed to be rescheduled since the room was contaminated with the hair in the package.

Manufacturer Narrative

The reported event was confirmed, however, the cause is unknown.Visual evaluation of the photo sample noted one opened (without original packaging), irrigation syringe.Visual inspection of the sample noted hair on the syringe barrel.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 production areas cleaning procedure".The device history record was reviewed and found nothing that could have caused or contributed to the reported event.21 cfr 801.116 outlines the conditions upon which a device is exempt from adequate directions as follows: "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." product catalog number 0935280 is deemed by appropriate subject matter experts (sme) to be within this definition.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.

• Brand Name: SYRINGE IRRIGATION BULK
• Type of Device: SYRINGE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8670121
• MDR Text Key: 147044113
• Report Number: 1018233-2019-02931
• Device Sequence Number: 1
• Product Code: KYZ
• UDI-Device Identifier: 10801741051378
• UDI-Public: (01)10801741051378(10)NGCZ3793
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,other
• Type of Report: Initial,Followup
• Report Date: 07/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Catalogue Number: 0935280
• Device Lot Number: NGCZ3793
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2019
• Date Manufacturer Received: 07/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other