MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD¿ PEN NEEDLE

Catalog Number	UNKNOWN
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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.Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: level a investigation complaint evaluation / complaint history check for the event(s) that occurred.Severity: s_2__; occurrence: unable to perform complaint lot history check due to an unknown lot number for needle bent npe & breaks off during use pe.Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.If samples are received in the future the complaint will be reopened for further investigation.Unable to perform dhr check due to an unknown lot number for needle bent npe & breaks off during use pe.Investigation conclusion: as no samples and/or photo(s) were received the investigation concluded: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.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: root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned.Rationale: based on the investigation, no additional investigation and no capa is required at this time.
Event or Problem Description
It was reported that unspecified bd¿ pen needle is bent and broke off during use.The following information was provided by the initial reporter: material no.Unknown batch no.Unknown.It was reported that non patient end is bent and twice the needle is missing from the patient end after injecting.Called nurse hot line about needle break and was told as long as he can't feel it he should be fine.Letter received, (b)(6) 2020, letter entered below: i am writing to you about your pen needles.My husband has been having trouble with them being bent on the inside of the plastic where you would place it to the pen.Also, twice he has used them and when he pulls it away from him the needle is gone.We don't know if it fell off after he pulled it out or stayed in his stomach.When it happen last month, i called the nurse hotline on his insurance and she told me that if he can't feel it he should be okay.She also said that if it kept happening then it could become a problem.I called your toll free line.I left a message.I get a call back, the lady who talked to me acted and sounded like we are dummies.My husband has been using your pen needles for a very long time.He always checks it before he uses them.He also knows how to put them on the pen.We just want you to be aware of the problem and if anyone else is having the same problems.If there are anymore bent ones inside, we will keep them and sent them to you.

• Brand Name: UNSPECIFIED BD¿ PEN NEEDLE
• Common Device Name: PEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 9733348
• Report Number: 2243072-2020-00249
• Device Sequence Number: 19554748
• Product Code: FMI
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/11/2020

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
• Operator of Device: Lay User/Patient
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2020
• Initial Report FDA Received Date: 02/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other