MAUDE Adverse Event Report: BECTON DICKINSON SYRINGE 0.3ML 31GA 6MM HALFUNIT 10BAGNLA; SYRINGE WITH NEEDLE

Catalog Number 324913

Device Problem Break (1069)

Patient Problem Pain (1994)

Event Date 03/10/2020

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.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 9098624, medical device expiration date: 2024-04-30, device manufacture date: 2019-08-26.Medical device lot #: 9119551, medical device expiration date: 2024-05-31, device manufacture date: 2019-07-17.Medical device lot #: unknown, medical device expiration: unknown, device manufacture date: unknown.

Event Description

It was reported during use the syringe 0.3ml 31ga 6mm halfunit 10bagnlav had the cannulas break off or pull out.Additional non reportable event type(s) were reviewed with the following rationale: needle point is blunt or dull; cannula crimped or bent.The following information was provided by the initial reporter: "some needles were bent, they were blunt and it hurt to use them, the needle stayed at the application site and the customer was able to withdraw it.".

Event Description

It was reported during use the syringe 0.3ml 31ga 6mm halfunit 10bagnlav had the cannulas break off or pull out.Additional non reportable event type(s) were reviewed with the following rationale: needle point is blunt or dull; cannula crimped or bent the following information was provided by the initial reporter: "some needles were bent, they were blunt and it hurt to use them, the needle stayed at the application site and the customer was able to withdraw it.".

Manufacturer Narrative

H.6.Investigation summary: customer returned (139) loose 31gx6mm, 0.3ml bd insulin syringes.Consumer reported some needles were bent, they were blunt and it hurt to use them, and a needle stayed at the application site and the customer was able to withdraw it.All 139 returned syringes were examined and it was observed that five syringes exhibited bent cannula.No evidence of manufacturing defect was observed on these syringes.None of the 139 returned syringes exhibited broken cannula.30 out of the remaining 134 syringes were selected and tested for point geometry, outer diameter and lube coverage.The following was observed (specs: outer diameter for 31g cannula: 0.0100¿- 0.0105¿): data: point outer diameter (in.) lube sample 1 good 0.0103 good sample 2 good 0.0103 good sample 3 good 0.0103 good sample 4 good 0.0103 good sample 5 good 0.0103 good sample 6 good 0.0103 good sample 7 good 0.0103 good sample 8 good 0.0103 good sample 9 good 0.0103 good sample 10 good 0.0103 good sample 11 good 0.0103 good sample 12 good 0.0103 good sample 13 good 0.0103 good sample 14 good 0.0103 good sample 15 good 0.0103 good sample 16 good 0.0103 good sample 17 good 0.0103 good sample 18 good 0.0103 good sample 19 good 0.0103 good sample 20 good 0.0103 good sample 21 good 0.0103 good sample 22 good 0.0103 good sample 23 good 0.0103 good sample 24 good 0.0103 good sample 25 good 0.0103 good sample 26 good 0.0103 good sample 27 good 0.0103 good sample 28 good 0.0103 good sample 29 good 0.0103 good sample 30 good 0.0103 good.All 30 tested syringes tested within specification.No evidence of manufacturing defect was observed.Since all 139 syringes were returned after use, and no manufacturing defects were observed, the probable cause of the bent cannulas is user error when using the syringes.If the user removes the cannula shield obliquely they may bend the cannula.A review of the device history record was completed for batch# 9098624.All inspections and challenges were performed per the applicable operations qc specifications.There were two (2) notifications [200818801, 200818591] noted that did not pertain to the complaint.A review of the device history record was completed for batch# 9119551.All inspections and challenges were performed per the applicable operations qc specifications.There were two (2) notifications [200821207, 200820186] noted that did not pertain to the complaint.Investigation conclusion: bd was able to duplicate or confirm the customer¿s indicated failure (needle bent) bd was not able to duplicate or confirm the customer¿s indicated failure (needle blunt, breaks off during use) complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.Root cause description: the possible root cause for this issue is: user error.No evidence of manufacturing related issues were observed on the returned samples.Since all 139 syringes were returned after use, the probable cause of the bent cannulas is user error when using the syringes.If the user removes the cannula shield obliquely they may bend the cannula.Root cause cannot be determined for the alleged defects (needle blunt, breaks off during use) because those issues are unconfirmed.Rationale: based on the investigation, no additional investigation and no capa is required at this time.

• Brand Name: SYRINGE 0.3ML 31GA 6MM HALFUNIT 10BAGNLA
• Type of Device: SYRINGE WITH NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 9907670
• MDR Text Key: 187017133
• Report Number: 2243072-2020-00532
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 04/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 324913
• Device Lot Number: SEE H.10
• Date Manufacturer Received: 03/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other