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

Catalog Number	UNKNOWN
Medical Device Problem Codes	Break (1069); Defective Device (2588)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/17/2020
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_1__; occurrence: unable to perform complaint lot history check due to an unknown lot number for needle broken npe & needle bent pe.Investigation summary: customer returned (1) open 4mm, 32g pen needle without the tear drop label, inner shield, or outer cover.Customer states that the needle is bent and the rear cannula end is broken.The returned pen needle was examined and exhibited a bent patient end of the cannula and a broken non patient end of the cannula.Unable to perform dhr check due to an unknown lot number for needle broken npe & needle bent pe.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.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: 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 broke and got stuck.The needle was also bent.The following information was provided by the initial reporter: material no.: unknown batch no.: unknown.It was reported that the rear cannula was broken and gets stuck.It was also reported the needle was bent.

• 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: 9667871
• Report Number: 2243072-2020-00137
• Device Sequence Number: 714580
• Product Code: FMI
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: UNKNOWN
• 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): 01/20/2020

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2020
• Initial Report FDA Received Date: 02/04/2020
• 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