MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD SYRINGE; PISTON SYRINGE

Catalog Number UNKNOWN

Device Problems Material Puncture/Hole (1504); Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/05/2021

Event Type  malfunction  

Manufacturer Narrative

"unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Date of event: unknown.The date received by manufacturer has been used.Medical device expiration date: unknown.The customer's address is unknown.(b)(6) usa has been used as a default.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).".

Event Description

It was reported that an unspecified number of unspecified bd syringes were damaged and had the needle through the shield during use.The following was reported by the initial reporter: "it was reported that the consumer found several needles to be installed crooked in the syringe and the needle point is wobbling.Also, the consumer has been stuck two times and the needle went through the cap.Verbatim: hello  a complaint came in last night ((b)(6) 2021) via (b)(6) direct message.We have replied and have asked for contact information from her, and advised her to contact this email directly if she is not comfortable providing contact information.We will follow up if she responds.From (b)(6): a number of needles i have taken from new bags in a sealed box appear to be installed crooked in the syringe.It can be seen plainly when looking at a syringe from the side, spinning the syringe slowly sees the needle point "wobbling" showing its off centered.Generally i ignore this, but i have been accidentally stuck 2x in the past week, one from my bad aim for the cap, but the second through no fault or mine- when the needle poked my finger *through* the cap as i readied it for disposal by recapping.What gives?".

Manufacturer Narrative

Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.A device history review could not be completed as no batch number was provided.

Event Description

It was reported that an unspecified number of unspecified bd syringes were damaged and had the needle through the shield during use.The following was reported by the initial reporter: "it was reported that the consumer found several needles to be installed crooked in the syringe and the needle point is wobbling.Also, the consumer has been stuck two times and the needle went through the cap.Verbatim: hello ¿ attached is a complaint that came in last night (1/3/21) via twitter direct message.We have replied and have asked for contact information from her, and advised her to contact this email directly if she is not comfortable providing contact information.We will follow up if she responds.From twitter: a number of needles i have taken from new bags in a sealed box appear to be installed crooked in the syringe.It can be seen plainly when looking at a syringe from the side, spinning the syringe slowly sees the needle point "wobbling" showing its off centered.Generally i ignore this, but i have been accidentally stuck 2x in the past week, one from my bad aim for the cap, but the second through no fault or mine- when the needle poked my finger *through* the cap as i readied it for disposal by recapping.What gives?".

• Brand Name: UNSPECIFIED BD SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 11233851
• MDR Text Key: 256427255
• Report Number: 2243072-2021-00165
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 02/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1