MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD¿ PEN NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number UNKNOWN

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/25/2018

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.Initial reporter: address unavailable.(b)(6) address used.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that there was a ¿strange light reflection¿ on the unspecified bd¿ pen needle.There was no report of exposure, injury, or medical intervention noted.

Manufacturer Narrative

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 due to unknown lot number.Based on the samples / photo(s) 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.Investigation conclusion: root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned.

Event Description

It was reported that there was a ¿strange light reflection¿ on the unspecified bd¿ pen needle.There was no report of exposure, injury, or medical intervention noted.

Event Description

It was reported that there was a ¿strange light reflection¿ on the unspecified bd¿ pen needle.There was no report of exposure, injury, or medical intervention noted.

Manufacturer Narrative

Correction: due to an it issue beginning on 7/3/2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: other.Device single use?: no.Device returned to manufacturer: no.

• Brand Name: UNSPECIFIED BD¿ PEN NEEDLE
• Type of Device: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 7696419
• MDR Text Key: 114672274
• Report Number: 2243072-2018-00988
• Device Sequence Number: 1
• Product Code: JKA
• 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,Followup
• Report Date: 08/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 06/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other