MAUDE Adverse Event Report: BECTON DICKINSON AND CO. BD ULTRA-FINE¿ SHORT PEN NEEDLES 8MM (5/16¿) 31G; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number 320109

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/08/2019

Event Type  Injury  

Manufacturer Narrative

Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It has been reported that the bd ultra-fine¿ short pen needles 8mm (5/16¿) 31g has been found with the cannula breaking off during use.The following has been provided by the initial reporter: it was reported daughter of consumer stated that the needle broke off in her mom's stomach when she was taking injection.Verbatim: daughter of consumer stated: needle broke off in her mom's stomach when she was taking injection.Went to emergency room.Ultrasound was done.Needle was located but did not remove.Hub discarded.Incident date: (b)(6) 2019.Lot: 6355684.Item: 320109.

Manufacturer Narrative

H.6.Investigation: no samples (including photos) were returned as of (b)(6) 2020 therefore the complaint could not be confirmed and the root cause is undetermined.A lot history review was carried out and no related non conformances were raised in association with this packaged lot concluding all inspections were performed per the applicable operations and met qc specifications.H3 other text : see h.10.

Event Description

It has been reported that the bd ultra-fine¿ short pen needles 8mm (5/16¿) 31g has been found with the cannula breaking off during use.The following has been provided by the initial reporter: it was reported daughter of consumer stated that the needle broke off in her mom's stomach when she was taking injection verbatim: daughter of consumer stated: needle broke off in her mom's stomach when she was taking injection went to emergency room ultrasound was done needle was located but did not remove hub discarded.Incident date: (b)(6).Lot: 6355684.Item: 320109.

• Brand Name: BD ULTRA-FINE¿ SHORT PEN NEEDLES 8MM (5/16¿) 31G
• Type of Device: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON AND CO.; pottery road; dun laoghaire co
• MDR Report Key: 9521876
• MDR Text Key: 172816847
• Report Number: 9616656-2019-01272
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 10885403801518
• UDI-Public: 10885403801518
• Combination Product (y/n): N
• PMA/PMN Number: K162516
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 01/10/2020

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: 320109
• Device Lot Number: 6355684
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/09/2019
• Initial Date FDA Received: 12/26/2019
• Supplement Dates Manufacturer Received: 12/09/2019
• Supplement Dates FDA Received: 01/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention