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U.S. Department of Health and Human Services

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

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BECTON DICKINSON UNSPECIFIED BD SYRINGE PISTON SYRINGE Back to Search Results
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?".
 
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Brand NameUNSPECIFIED BD SYRINGE
Type of DevicePISTON SYRINGE
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
brett wilko
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key11233851
MDR Text Key256427255
Report Number2243072-2021-00165
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/26/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/26/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/26/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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