MAUDE Adverse Event Report: BECTON DICKINSON AND CO. 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	07/15/2020
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.(b)(4).Investigation summary: level a investigation - complaint evaluation / complaint history check for the event(s) that occurred.Severity: s_1__; occurrence: unable to perform complaint lot history check due to an unknown lot number for needle bent & needle broken npe.A review of all risk management documents as per cp60125a for the product family of the device involved in this complaint (pen needle, needle bent & needle broken npe), was performed and it was determined that the potential risk of this specific reported incident was captured and addressed.Investigation summary: customer returned one (1) used 32g x 4mm bd pen needle without a cover, tear drop label, or inner shield attached.Consumer reported needle (s) bent, rear cannula end is broken + gets stuck.The returned pen needle was examined, and it was observed that the non-patient end (npe) cannula was bent; no damage to the patient end (pe) cannula was observed.No evidence of manufacturing defect was observed.Since the sample was returned after use, and no manufacturing defects were observed, the probable cause of the bent npe cannula is user error when attaching the pen needle to a pen injector.Unable to perform a dhr review due to an unknown lot number for needle bent & needle broken npe.Investigation conclusion: based on the samples and/or photo(s) received the investigation concluded: confirmed: bd was able to duplicate or confirm the customer¿s indicated failure (bent npe cannula).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.It is bd¿s experience that the non-patient end breakage and bending is directly associated with the placing of the needle onto the pen device by the user.If the non-patient end of the needle is not placed centrally to the pen device, then instead of the non-patient end of the needle piercing the rubber septum of the vial, it hits hard material and can be bent/broken when fitted to the pen.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 cannula was broken.The following information was provided by the initial reporter: material no.Unknown batch no.Unknown.It was reported that the needle was bent and non patient end was broken.

• Brand Name: UNSPECIFIED BD PEN NEEDLE
• Common Device Name: PEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON AND CO.; pottery road; dun laoghaire co
• MDR Report Key: 10315082
• Report Number: 2243072-2020-01133
• Device Sequence Number: 810936
• Product Code: FMI
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2020
• Initial Report FDA Received Date: 07/23/2020
• 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