MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD POSIFLUSH¿ SYRINGE; PRE-FILLED SYRINGE

Catalog Number UNKNOWN

Device Problem Difficult or Delayed Activation (2577)

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

Event Date 10/01/2019

Event Type  malfunction  

Manufacturer Narrative

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.Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Initial reporter phone #: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that the safety mechanism is difficult to use with one hand with an unspecified bd posiflush¿ syringe.The following information was provided by the initial reporter: it was reported that safety is difficult to use with one hand.This has been an ongoing problem over the course of several weeks.In pediatrics, we are dealing with wiggling children and while we do our best to control the child, we only have one hand to close the needles after use.Often when trying to push the lock, the needle bends and won¿t allow for complete closure.

Event Description

It was reported that the safety mechanisim is difficult to use with one hand with an unspecified bd posiflush¿ syringe.The following information was provided by the initial reporter: it was reported that safety is difficult to use with one hand.This has been an ongoing problem over the course of several weeks.In pediatrics, we are dealing with wiggling children and while we do our best to control the child, we only have one hand to close the needles after use.Often when trying to push the lock, the needle bends and won¿t allow for complete closure.

Manufacturer Narrative

Investigation: no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified and the root cause could not be determined.A device history record could not be evaluated as the lot number is unknown.

• Brand Name: UNSPECIFIED BD POSIFLUSH¿ SYRINGE
• Type of Device: PRE-FILLED SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 9197825
• MDR Text Key: 172686343
• Report Number: 2243072-2019-02315
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 11/14/2019

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: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 10/01/2019
• Initial Date FDA Received: 10/16/2019
• Supplement Dates Manufacturer Received: 10/01/2019
• Supplement Dates FDA Received: 11/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other