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.Device was not returned.

Event Description

It was reported that the bulb had a hair stuck inside of it.The issue was noted prior to use.

Manufacturer Narrative

The reported event was confirmed, however, the cause is unknown.Visual evaluation of the returned sample noted one opened (without original packaging), bulb syringe.Visual inspection of the sample noted the presence of a hair loose inside the syringe between the bulb and the syringe body.This is out of specification per inspection procedure which states, "no hair is permitted on the product." 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 the 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.

Event Description

It was reported that the bulb had a hair stuck inside of it.The issue was noted prior to use.

• 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: 9727013
• MDR Text Key: 183969084
• Report Number: 1018233-2020-01116
• 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: 03/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2020
• 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: NGDV1313
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2020
• Date Manufacturer Received: 03/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1