MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD SYRINGE

Catalog Number UNKNOWN

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 07/26/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that an unspecified bd syringe.The following information was provided by the initial reporter: "it was reported that the ns syringe was removed from the tubing and the tip of the syringe broke off and remained in the tubing.Event description per attached email and excel file states: when going to give medication through medline.The 0.9 ns syringe was removed from tubing and the tip of the syringe was broken off and remained in the tubing.New line set up was made and the defective tubing removed and turned in.".

Manufacturer Narrative

H.6.Investigation: bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided.Bd was not able to duplicate or confirm the customer¿s indicated failure as no sample, batch, or lot code was provided.Dhr could not be performed due to unknown lot#.H3 other text : see h.10.

Event Description

It was reported that an unspecified bd syringe.The following information was provided by the initial reporter: "it was reported that the ns syrine was removed from the tubing and the tip of the syringe broke off and remained in the tubing.Event description per attached email and excel file states: when going to give medication through medline.The 0.9 ns syringe was removed from tubing and the tip of the syringe was broken off and remained in the tubing.New line set up was made and the defective tubing removed and turned in.".

• Brand Name: UNSPECIFIED BD SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 9812760
• MDR Text Key: 189161365
• Report Number: 2243072-2020-00362
• 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: other,user facility
• Type of Report: Initial,Followup
• Report Date: 03/10/2020

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
• Device Operator: Other
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/19/2020
• Initial Date FDA Received: 03/10/2020
• Supplement Dates Manufacturer Received: 02/19/2020
• Supplement Dates FDA Received: 03/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other