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

Catalog Number UNKNOWN

Device Problem Failure to Deliver (2338)

Patient Problem Pain (1994)

Event Date 12/02/2019

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 for this field.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that the needles used with the unspecified bd¿ syringe were "too long" and pain was experienced during the injection as a result.The following information was provided by the initial reporter: "spouse of consumer called in to report, the needles to syringes her husband is using, are too long" stated, he's experiencing pain when he injects with them.Stated, she has small needle lengths and long ones that are mixed in a storage box she uses.Just said, the needles were smaller.She kept saying, he normally gets 3/10ml.

Manufacturer Narrative

H.6.Investigation: customer returned (56) loose 29gx12.7mm, 0.3ml bd insulin syringes.Spouse of consumer called in to report, the needles to syringes her husband is using, are too long; stated, he's experiencing pain when he injects with them.Out of the 56 returned syringes 30 were examined, then tested for needle length, point geometry, outer diameter and lube coverage.All 30 tested samples tested within specification.No evidence of manufacturing defect was observed on the samples, therefore, the alleged issues could not be confirmed.Root cause cannot be determined at this time as the issue is unconfirmed.Unable to perform a dhr review for dimension (too long) and needle pain due to unknown lot number.H3 other text : see h.10.

Event Description

It was reported that the needles used with the unspecified bd¿ syringe were "too long" and pain was experienced during the injection as a result.The following information was provided by the initial reporter: "spouse of consumer called in to report, the needles to syringes her husband is using, are too long" stated, he's experiencing pain when he injects with them.Stated, she has small needle lengths and long ones that are mixed in a storage box she uses.Just said, the needles were smaller.She kept saying, he normally gets 3/10ml.

• 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: 9483215
• MDR Text Key: 176966936
• Report Number: 2243072-2019-02838
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 01/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 12/02/2019
• Initial Date FDA Received: 12/17/2019
• Supplement Dates Manufacturer Received: 12/02/2019
• Supplement Dates FDA Received: 01/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other