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

Catalog Number UNKNOWN

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/09/2019

Event Type  malfunction  

Manufacturer Narrative

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.Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Initial reporter: address unavailable.Bd corporate address used.Device manufacture date: unknown.Investigation summary: level b investigation complaint evaluation / complaint history check for the event(s) that occurred.Severity: s_3__; occurrence: unable to perform complaint lot history check for needle breaks off during use (pe) due to unknown lot number.Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.Unable to perform dhr check for needle breaks off during use (pe) due to unknown lot number.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 Description

It has been reported that the unspecified bd¿ pen needle has been found experiencing two occurrences of the needle breaking off during use.The following has been provided by the initial reporter: material no.Unknown batch no.Unknown.It was reported that needle broke off during use.This (b)(4) records issue of needle breaks off during use on an unknown occurrence date.Verbatim: issue: spouse reported needle disappeared on his stomach, they could not find it on the floor.They called the nurse hotline, they stated if nothing happens not to worry.Incident date: unknown.Occurrence: 2.Item#: unknown.Lot#: unknown.Consumer uses new needle each time of his injection.He visually tests the needle to see if it is straight.He firmly attaches the pen needle, spouse of a consumer responded he has been a long time consumer and he knows what he is doing.

Event Description

It has been reported that the unspecified bd¿ pen needle has been found experiencing two occurrences of the needle breaking off during use.The following has been provided by the initial reporter: material no.Unknown.Batch no.Unknown.It was reported that needle broke off during use.This pr 1331855 records issue of needle breaks off during use on an unknown occurrence date.Verbatim: issue: spouse reported needle disappeared on his stomach, they could not find it on the floor.They called the nurse hotline, they stated if nothing happens not to worry.Incident date-unknown occurrence-2 item# unknown.Lot# unknown.Consumer uses new needle each time of his injection.He visually tests the needle to see if it is straight.He firmly attaches the pen needle, spouse of a consumer responded he has been a long time consumer and he knows what he is doing.

Manufacturer Narrative

Correction: initial mdr submission stated "device evaluation anticipated, but not yet begun".Evaluation was completed and included in initial mdr submission.H3 other text : see h.10.

• Brand Name: UNSPECIFIED BD¿ PEN NEEDLE
• Type of Device: PEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 9521825
• MDR Text Key: 177850116
• Report Number: 2243072-2019-02899
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 01/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other