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

Catalog Number UNKNOWN

Device Problem Material Separation (1562)

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

Event Date 03/27/2019

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.(b)(4).Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Device evaluated by mfr: 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 unspecified bd¿ syringe with needle hub separated when attempting to depress the plunger during use.The consumer reported 2 occurrences of this event.The following information was provided by the initial reporter: description of issue: customer reported issue with needle tip bending when she tries to fill her cartridge causing her to throw away the needle tip(2 times).Customer also reported issue with needle tip blowing off the syringe when she tries to compress the plunger causing her to replace the needle tip (2 times).Customer alleged issues have happened over the last few weeks (event date approx) and bg unaffected.Did the customer insert the needle into the cartridge and encounter fill resistance? no.Number of occurrences: 3.Item number: 3 ml syringe ¿ 309657.Product lot number: m137739.Are samples available for investigation? no.Did issue cause any injury? if yes, what type of injury? no.Medical intervention needed? if yes, who was the 3rd party and what was the assistance/treatment? no.

Manufacturer Narrative

Investigation summary: no samples displaying the condition reported are available for examination so we were unable to fully investigate this incident.No root cause can be determined as no samples were received.A device history review could not be completed as no batch number was provided.Based on no sample, the investigation concluded, bd was not able to verify the indicated failure.

Event Description

It was reported that the unspecified bd¿ syringe with needle hub separated when attempting to depress the plunger during use.The consumer reported 2 occurrences of this event.The following information was provided by the initial reporter: 1.Description of issue: customer reported issue with needle tip bending when she tries to fill her cartridge causing her to throw away the needle tip(2 times).Customer also reported issue with needle tip blowing off the syringe when she tries to compress the plunger causing her to replace the needle tip (2 times).Customer alleged issues have happened over the last few weeks (event date approx) and bg unaffected.2.Did the customer insert the needle into the cartridge and encounter fill resistance? no.3.Number of occurrences: 3.4.Item number 3 ml syringe ¿ 309657.5.Product lot number: m137739.6.Are samples available for investigation? no.7.Did issue cause any injury? if yes, what type of injury? no.8.Medical intervention needed? if yes, who was the 3rd party and what was the assistance/treatment? no.

• Brand Name: UNSPECIFIED BD SYRINGE WITH NEEDLE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8504670
• MDR Text Key: 147604349
• Report Number: 2243072-2019-00714
• 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,other
• Type of Report: Initial,Followup
• Report Date: 04/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 64 YR