MAUDE Adverse Event Report: BECTON DICKINSON BD SAFE-CLIP¿; NEEDLE CLIPPING DEVICE

Catalog Number	328235
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B.3.Date of event: unknown.The date received by manufacturer has been used for this field.D.4.Medical device expiration date: na.E.1.The customer's address is unknown.New jersey, usa has been used as a default.H.3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd safe-clip¿ had a biohazard sticker on it.This complaint was created to capture the 1st of 2 related incidents.The following information was provided by the initial reporter: "i recently purchased bd safe-clip: ref # (b)(4).Lot #2235002.And the one i got and opened today: 1) already has a biohaz sticker on it, and 2) rattles like it already has clipped needles in it.Subsequently, i went online and looked up product reviews.Apparently, there are several customers who have complained about the exact same thing.What's going on? are we getting used biohazard sharps containers sent out to us? i also work in a xxx (b)(6) laboratory and we always rely on bd to supply our syringes, needles, etc.For bacterial endotoxin assays and such.We have never had any problem with the lab shipments.So, it's just really weird that the direct-to-consumer sales arrive in such consistently questionable conditions.Or, the thing just rattles and there aren't any stranger's used needles in there.".
Event or Problem Description
It was reported that the bd safe-clip¿ had a biohazard sticker on it.This complaint was created to capture the 1st of 2 related incidents.The following information was provided by the initial reporter: "i recently purchased bd safe-clip: ref #(b)(4), lot #2235002.And the one i got and opened today: 2) rattles- like it already has clipped needles in it.Subsequently, i went online and looked up product reviews.Apparently, there are several customers who have complained about the exact same thing.What's going on? are we getting used biohazard sharps containers sent out to us? i also work in a (b)(6) and we always rely on bd to supply our syringes, needles, etc.For bacterial endotoxin assays and such.We have never had any problem with the lab shipments.So, it's just really weird that the direct-to-consumer sales arrive in such consistently questionable conditions.
Additional Manufacturer Narrative
The following fields have been updated due to additional information: h.6.Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.This is the 1st complaint for the reported lot number.A review of the manufacturing records was performed, and no non-conformances were raised in association with this type of event for this lot.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.Based on the above, no additional investigation and no corrective/preventative action (capa) or situational analysis (sa) is required at this time.

• Brand Name: BD SAFE-CLIP¿
• Common Device Name: NEEDLE CLIPPING DEVICE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17795403
• Report Number: 2243072-2023-01699
• Device Sequence Number: 2189299
• Product Code: FMI
• UDI-Device Identifier: 00382903282357
• UDI-Public: 00382903282357
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K943683
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2023

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
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 328235
• Device Lot Number: 2235002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2023
• Supplement Date Received by Manufacturer: 12/07/2023
• Initial Report FDA Received Date: 09/21/2023
• Supplement Report FDA Received Date: 12/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown