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

Event Description

It was reported that the irrigation syringe contained black and brown particulates on the outside of the device and along the inside of the device as well.

Manufacturer Narrative

The reported event was confirmed.There was a black speck taped onto the outside of the bulb of the syringe (loose) measuring 0.30 sq mm in size, there was additional black spec taped to the outside of the syringe (loose) measuring 0.40 sq mm in size.Although the reported event was confirmed, the root cause could not be determined.A potential failure mode could be "product with foreign material / hair; loose or embedded." a potential root cause for this failure could be "defective / contaminated components from supplier." 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 0035280 is deemed by appropriate subject matter experts (sme) to be within this definition.

Event Description

It was reported that the irrigation syringe contained black and brown particulates on the outside of the device and along the inside of the device as well.

• Brand Name: SYRINGE IRRIGATION BULK
• Type of Device: IRRIGATION SYRINGE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: yonic anderson ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 8669174
• MDR Text Key: 147046951
• Report Number: 1018233-2019-02906
• Device Sequence Number: 1
• Product Code: KYZ
• UDI-Device Identifier: 10801741051378
• UDI-Public: (01)10801741051378
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/31/2019

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: Other
• Device Expiration Date: 11/30/2022
• Device Catalogue Number: 0935280
• Device Lot Number: NGBY1347
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2019
• Initial Date Manufacturer Received: 05/14/2019
• Initial Date FDA Received: 06/04/2019
• Supplement Dates Manufacturer Received: 07/19/2019
• Supplement Dates FDA Received: 07/31/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1