MAUDE Adverse Event Report: BD CARIBE LTD. NEEDLE SP S/SU 25GA 4-11/16IN QUINCKE; ANESTHESIA CONDUCTION NEEDLE

Model Number 405234

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

Patient Problem No Patient Involvement (2645)

Event Date 05/20/2020

Event Type  malfunction  

Manufacturer Narrative

There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 8285784, medical device expiration date: 2023-10-31, device manufacture date: 2018-11-13.Medical device lot #: 9035553, medical device expiration date: 2024-02-29, device manufacture date: 2019-03-20.Fda notified: the initial reporter also notified the fda on (b)(6) 2020 via medwatch # mw509507.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that 2 needles sp s/su 25 ga 4-11/16 in quincke from lot 8285784, and 1 needle from lot 9035553 had dark flecks of foreign residue on them before use.The following information was provided by the initial reporter: "hard residue flecks have been found on a few bd ref# 405234 quincke needles.Approximately 3-4 of these needles had a small, dark colored fleck of residue attached to the shaft of the needle.This has been over the past six months and only one needle will show a defect at any time given.These needles come from at least two different lot numbers, including lot# 8285784 and lot #9035553.None of the defective needles were used for procedure.".

Event Description

It was reported that 2 needles sp s/su 25ga 4-11/16in quincke from lot 8285784, and 1 needle from lot 9035553 had dark flecks of foreign residue on them before use.The following information was provided by the initial reporter: "hard residue flecks have been found on a few bd ref# (b)(4) quincke needles.Approximately 3-4 of these needles had a small, dark colored fleck of residue attached to the shaft of the needle.This has been over the past six months and only one needle will show a defect at any time given.These needles come from at least two different lot numbers, including lot# 8285784 and lot #9035553.None of the defective needles were used for procedure.".

Manufacturer Narrative

H6: investigation summary: no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified.A review of the internal manufacturing device records and raw material history files for the reported lot number was performed and no recorded quality problems or rejections to this incident were found.Based on the quality team's investigation, the root cause of this incident cannot be determined.However, new actions have been implemented to mitigate new events of fm after the manufacturing of complaint lots.

• Brand Name: NEEDLE SP S/SU 25GA 4-11/16IN QUINCKE
• Type of Device: ANESTHESIA CONDUCTION NEEDLE
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• MDR Report Key: 10624089
• MDR Text Key: 211061627
• Report Number: 2618282-2020-00078
• Device Sequence Number: 1
• Product Code: BSP
• UDI-Device Identifier: 30382904052349
• UDI-Public: 30382904052349
• Combination Product (y/n): N
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 11/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 405234
• Device Catalogue Number: 405234
• Device Lot Number: SEE SECTION H.10.
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other