MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD SYRINGE

Catalog Number UNKNOWN

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem Laceration(s) (1946)

Event Date 08/15/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Device expiration date: 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 an unspecified number of an unspecified bd syringe experienced a molding defect with sharp protrusions which was noted during use.The following information was provided by the initial reporter: material no: unknown, batch no: unknown.Event description -consumer reported when she pulls on plunger rod, the "flanges" are not smooth and she hurts her fingers.Stated, bd should make "flanges" smoother.Stated, she re-uses because she can't afford them.Did not seek medical.Incident date unknown.Stated, some friends of hers experienced the same issue, "someone almost loss a finger from cutting themselves" on flanges located on plunger rod.Does not have samples to send back.".

Manufacturer Narrative

H.6.Investigation: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.Unable to perform dhr check for flange damaged and harm/injury due to unknown lot number.H3 other text : see h.10.

Event Description

It was reported that an unspecified number of an unspecified bd syringe experienced a molding defect with sharp protrusions which was noted during use.The following information was provided by the initial reporter: material no: unknown batch no: unknown.Event description -consumer reported when she pulls on plunger rod, the "flanges" are not smooth and she hurts her fingers.Stated, bd should make "flanges" smoother.Stated, she re-uses because she can't afford them.Did not seek medical.Incident date unknown.Stated, some friends of hers experienced the same issue, "someone almost loss a finger from cutting themselves" on flanges located on plunger rod.Does not have samples to send back.".

• Brand Name: UNSPECIFIED BD SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8966127
• MDR Text Key: 157384016
• Report Number: 2243072-2019-01917
• 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: consumer,other
• Type of Report: Initial,Followup
• Report Date: 09/10/2019

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: Lay User/Patient
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 08/15/2019
• Initial Date FDA Received: 09/05/2019
• Supplement Dates Manufacturer Received: 08/15/2019
• Supplement Dates FDA Received: 09/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other