MAUDE Adverse Event Report: BECTON DICKINSON AND CO. PEN NDL 32G 4MM HP; PEN NEEDLE

Catalog Number 320555

Device Problem Misconnection (1399)

Patient Problems Overdose (1988); Underdose (2542)

Event Date 02/22/2020

Event Type  Injury  

Manufacturer Narrative

Investigation summary: customer returned a photo of a tear drop label for a 4mm, 32g pen needle from lot # 9072616.Customer states that went to inject, the needle would not penetrate her skin when she depressed the plunger if the penlet, the insulin was slow and difficult to dispense: result under dosage.The photo was examined and did not show the pen needles in question, only the tear drop label.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.Investigation conclusion: bd was not able to duplicate or confirm the customer¿s indicated failure.Root cause description: root cause cannot be determined at this time as the issue is unconfirmed.

Event Description

" captures: needle blunt, difficult/unable to operate (slow & difficult to dispense), glucose level (over dosage) with date of occurrence (b)(6) 2020.It was reported that the needle was dull and the insulin was difficult to dispense.Verbatim: i don¿t believe the three suspect needles were sharp enough, the first time it happened i didn¿t get the needle in.I didn¿t thing anything of it and disposed of the offending needle in the biohazard disposal.And started again.It happened again thursday (b)(6) when i went to inject and the needle wouldn¿t penetrate my skin¿ when i depressed the plunger of the penlet, the insulin was slow and difficult to dispense.Result: under dosage.However two days later, on saturday (b)(6), i went to inject and the same thing happened again.(note: injection site is consistently moved around.) this time pelnet got out 5u (with difficulty) but the insulin rolled out onto my skin.I put this needle in the biohazard disposal and got a new needle and started again.The second attempt worked.Result: over dosage but not by much if any at all.I saved the ¿peel off¿ label and took pictures of it but unfortunately did not save the defective needle as not to get it mixed up with the new one.I counted the remaining needled and have 99 needles left from two boxes each of 100.I buy two boxes of 100 at a time so i assume the 200 were all the same lot number.I no longer have the boxes they came in as i throw them out once i open them.I do have the receipt as i submit it to out benefits provider for reimbursement.Per update by us com on 06/03/2020 from phone call on 2020-03-06 17:07:06: reached out to consumer: discarded samples stated, primes before injection stated, number were not affected." 3 of 3 complaints this event occurred on (b)(6) 2020.

• Brand Name: PEN NDL 32G 4MM HP
• Type of Device: PEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON AND CO.; pottery road; dun laoghaire co
• Manufacturer (Section G): BECTON DICKINSON AND CO.; pottery road; dun laoghaire co
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 9814465
• MDR Text Key: 191683669
• Report Number: 9616656-2020-00208
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 00382903205554
• UDI-Public: 382903205554
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2024
• Device Catalogue Number: 320555
• Device Lot Number: 9072616
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/25/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/13/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention