MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD NEEDLE

Catalog Number UNKNOWN

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Needle Stick/Puncture (2462)

Event Date 04/15/2019

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.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: bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided.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.Investigation conclusion: bd was not able to duplicate or confirm the customer¿s indicated failure as no sample, batch, or lot code was provided.Root cause description: this complaint will be entered into the complaint management system and will be tracked & trended for future occurrences.Rationale: no sample, lot, or batch provided.

Event Description

It was reported that unspecified bd¿ needle protector fell off and caused a needlestick injury.The following information was provided by the initial reporter: material no.Unknown, batch no.Unknown.It was reported an employee got stuck with a needle because the protector fell off.I have received a safety report from our manufacturing plant, reporting an incident where an employee got stuck with a needle because the protector fell off.Due to this incident i am required to reach out to supplier to confirm what checks are currently in place to prevent this from happening in the future.Our quality team has also been notified of the below and they will actually submit on their end with additional information they are gathering.

• Brand Name: UNSPECIFIED BD NEEDLE
• Type of Device: NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 8570812
• MDR Text Key: 143804022
• Report Number: 2243072-2019-00833
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2019
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/15/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other