MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD ULTRASAFE; PISTON SYRINGE

Catalog Number UNKNOWN

Device Problem Misconnection (1399)

Patient Problem No Patient Involvement (2645)

Event Date 07/30/2019

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.Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It has been reported that one unspecified bd¿ ultrasafe has been found experiencing inability to function before use.The following has been provided by the initial reporter: to the spring not working and the patient was unable to use the pfs.

Manufacturer Narrative

H.6.Investigation summary: a sample was not returned for evaluation.A review of the device history record could not be performed as a lot number and catalog were not provided for this incident.Conclusion: without a sample, an absolute root cause for this incident cannot be determined as bd was not able to duplicate or confirm the customer¿s indicated failure mode.H3 other text : see section h.10.

Event Description

It has been reported that one unspecified bd¿ ultrasafe has been found experiencing inability to function before use.The following has been provided by the initial reporter: to the spring not working and the patient was unable to use the pfs.

• Brand Name: UNSPECIFIED BD ULTRASAFE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 9083107
• MDR Text Key: 174741206
• Report Number: 2243072-2019-02056
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Type of Report: Initial,Followup
• Report Date: 09/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2019
• 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
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other