MAUDE Adverse Event Report: BECTON DICKINSON AND CO. BD ULTRA FINE PEN NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number 320109

Device Problems Break (1069); Leak/Splash (1354)

Patient Problems Underdose (2542); Device Embedded In Tissue or Plaque (3165)

Event Date 06/04/2019

Event Type  Injury  

Manufacturer Narrative

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

Material no: 320109; batch no: unknown (provided 8275934, 8255563).It was reported by the consumer that during use of the bd ultra fine¿ pen needle when injecting insulin, felt liquid running down their stomach and saw it was coming from the pen needle.Felt stomach for trace of the needle point that went away on further examination.Went to doctors for x-ray.X-ray did not show anything.Stated no follow up necessary with doctor.The following information was provided by the initial reporter: felt liquid running down stomach and saw that it was coming from pen needle.Took out pen and found no needle point.Felt stomach for trace of needle point but felt only a small prick that went away on further examination.Bd ultra fine short 8mm.Consumer provided two lot numbers but she's not sure which lot was affected.Stated part of needle broke off, she can still see a little piece sticking out at patient end.Stated she can't be sure if needle broke off in her injection site.X-ray did not show anything.Stated no follow up necessary with doctor.Stated using product for 25 years, never had issue cl.Consumer provided two lots: 8275934, 8255563.

Manufacturer Narrative

Investigation: customer returned (1) 31g x 8mm bd pen needle without a tear drop label attached.Two separated tear drop labels were provided, one from lot 8255563 and one from lot 8275934.Consumer reported felt liquid running down stomach and saw that it was coming from pen needle¿ took out pen and found no needle point.The returned sample was examined and exhibited a broken patient end (pe) cannula.Further examination using a microscope revealed a deep indentation in the epoxy and hub area, possibly caused by the cannula during the manufacturing process, which could lead to pe cannula breakage.The broken pe cannula would be the cause of the leakage reported by the customer.A lot history review was carried out and no related non conformance's were raised in association with these packaged lot numbers concluding all inspections were performed per the applicable operations and met qc specifications.Root cause of this defect is misalignment of the shield to the hub at the shielding station.Capa# (b)(4) was initiated.

Event Description

Material no: 320109 batch no: unknown (provided 8275934, 8255563) it was reported by the consumer that during use of the bd ultra fine¿ pen needle when injecting insulin, felt liquid running down their stomach and saw it was coming from the pen needle.Felt stomach for trace of the needle point that went away on further examination.Went to doctors for x-ray.X-ray did not show anything.Stated no follow up necessary with doctor.The following information was provided by the initial reporter: felt liquid running down stomach and saw that it was coming from pen needle.Took out pen and found no needle point.Felt stomach for trace of needle point but felt only a small prick that went away on further examination.Bd ultra fine short 8mm.Consumer provided two lot numbers but she's not sure which lot was affected.Stated part of needle broke off, she can still see a little piece sticking out at patient end.Stated she can't be sure if needle broke off in her injection site.X-ray did not show anything.Stated no follow up necessary with doctor.Stated using product for 25 years, never had issue cl consumer provided two lots: 8275934, 8255563.

Manufacturer Narrative

Investigation: customer returned photos of a pen needle.Customer states that when injecting insulin, felt liquid running down their stomach and saw it was coming from the pen needle and there was no needle point.The attached photos were examined and exhibited a broken patient end of the cannula, which could cause leakage.A lot history review was carried out on each of the reported lot numbers 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.Possible root causes for a broken needle include: bending/re-straightening of the cannula by the customer the following fields were updated due to corrected information: medical device lot #: 8275934.Medical device expiration date: 2023-09-30.Device manufacture date: 2018-10-02.Medical device lot #: 8255563.Medical device expiration date: 2023-09-30.Device manufacture date: 2018-09-12.

Event Description

Material no: 320109 batch no: unknown (provided 8275934, 8255563).It was reported by the consumer that during use of the bd ultra fine¿ pen needle when injecting insulin, felt liquid running down their stomach and saw it was coming from the pen needle.Felt stomach for trace of the needle point that went away on further examination.Went to doctors for x-ray.X-ray did not show anything.Stated no follow up necessary with doctor.The following information was provided by the initial reporter: felt liquid running down stomach and saw that it was coming from pen needle.Took out pen and found no needle point.Felt stomach for trace of needle point but felt only a small prick that went away on further examination.Bd ultra fine short 8mm.Consumer provided two lot numbers but she's not sure which lot was affected.Stated part of needle broke off, she can still see a little piece sticking out at patient end.Stated she can't be sure if needle broke off in her injection site.X-ray did not show anything.Stated no follow up necessary with doctor.Stated using product for 25 years, never had issue cl consumer provided two lots: 8275934, 8255563.

• Brand Name: BD ULTRA FINE PEN NEEDLE
• Type of Device: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON AND CO.; pottery road; dun laoghaire co
• MDR Report Key: 8704886
• MDR Text Key: 148213410
• Report Number: 9616656-2019-00539
• Device Sequence Number: 1
• Product Code: FMF
• 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,Followup
• Report Date: 08/28/2019

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: SEE H.10
• Initial Date Manufacturer Received: 06/04/2019
• Initial Date FDA Received: 06/17/2019
• Supplement Dates Manufacturer Received: 06/04/2019; 06/04/2019
• Supplement Dates FDA Received: 07/05/2019; 08/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention