MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE CLIPPING DEVICE SAFE CLIP; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number 328235

Device Problem Failure to Cut (2587)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/10/2020

Event Type  malfunction  

Manufacturer Narrative

Oem manufacturer: (b)(4).Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: na.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 the needle clipping device safe clip stopped clipping needles during use.The following information was provided by the initial reporter: "consumer reported she purchased a safe clip about 2 months ago and it suddenly stopped clipping the needles.".

Manufacturer Narrative

Correction: the customer provided an additional lot#.The following fields have been updated: b.5.Describe event or problem: it was reported that 1 needle clipping device safe clip from lot 8341034 and 1 device from lot 5057351 stopped clipping needles during use.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: d.4.Medical device lot #: 8341034.D.4.Medical device expiration date: na.H.4.Device manufacture date: 2018-12-27.D.4.Medical device lot #: 5057351.D.4.Medical device expiration date: na.H.4.Device manufacture date: 2015-03-16.

Event Description

It was reported that 1 needle clipping device safe clip from lot 8341034 and 1 device from lot 5057351 stopped clipping needles during use.The following information was provided by the initial reporter: "consumer reported she purchased a safe clip about 2 months ago and it suddenly stopped clipping the needles.".

Event Description

It was reported that 1 needle clipping device safe clip from lot 8341034 and 1 device from lot 5057351 stopped clipping needles during use.The following information was provided by the initial reporter: "consumer reported she purchased a safe clip about 2 months ago and it suddenly stopped clipping the needles.".

Manufacturer Narrative

The following fields were updated due to additional information: d.10.Device available for eval?: yes d.10.Returned to manufacturer on: 10/1/2020 h.6.Investigation: customer returned one (1) used bd safeclip device from lot 5057351.Consumer reported she purchased a safe clip about 2 months ago and it suddenly stopped clipping the needles.No samples from lot 8341034 were returned, therefore, the alleged issue for samples from this lot number could not be confirmed.The returned sample was examined, then tested by clipping test cannula: the safe clip was able to clip properly.No evidence of manufacturing defect was observed.Since the sample was returned after use, and no manufacturing defects were observed, the alleged issue could not be confirmed.According with the dhr review information attached, the problem ¿not clipping¿ has no nhb assembly process relation, all samples of safe clip disposable cutter (usa) passed functional test (sample plan c=0 and aql=1).H3 other text : see h.10.

• Brand Name: NEEDLE CLIPPING DEVICE SAFE CLIP
• Type of Device: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 10611020
• MDR Text Key: 210021585
• Report Number: 2243072-2020-01539
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 00382903282357
• UDI-Public: 00382903282357
• Combination Product (y/n): N
• PMA/PMN Number: K943683
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 328235
• Device Catalogue Number: 328235
• Device Lot Number: SEE SECTION H.10.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2020
• Date Manufacturer Received: 09/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other