MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD¿¿ ORAL SYRINGE WITH TIP CAP; LIQUID MEDICATION DISPENSER

Catalog Number 305210

Device Problem Break (1069)

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

Event Date 01/09/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 8236737.Medical device expiration date: n/a.Device manufacture date: 2018-08-24.Medical device lot #: 8263592.Medical device expiration date: n/a.Device manufacture date: 2018-09-20.Medical device lot #: 8263594.Medical device expiration date: n/a.Device manufacture date: 2018-09-20.Medical device lot #: 8263595.Medical device expiration date: n/a.Device manufacture date: 2018-09-20.(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.

Event Description

It was reported that before use of the bd¿ oral syringe with tip cap plunger rods were broken.

Event Description

It was reported that before use of the bd¿ oral syringe with tip cap plunger rods were broken.

Manufacturer Narrative

Investigation: three photos were received and evaluated.The photos depicted three amber oral 3ml syringes with plunger rods pulled up.Samples reported to be from batch #8236737 (b)(4).All 3 plunger rods had one of their ribs cracked near the thumb rest.The damage observed is rejectable per product specification.No samples have been received for the other 3 batches.A complaint history check was performed for all of the batches.No complaints for any related defects have been received from other customers for any of the batches to date.Potential root cause for the damaged plunger rod defect is associated with the assembly process.No corrective actions are necessary based on the defective rate identified.

• Brand Name: BD¿¿ ORAL SYRINGE WITH TIP CAP
• Type of Device: LIQUID MEDICATION DISPENSER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8287380
• MDR Text Key: 134447172
• Report Number: 1213809-2019-00128
• Device Sequence Number: 1
• Product Code: KYW
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 02/15/2019

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: Other
• Device Catalogue Number: 305210
• Device Lot Number: SEE H.10
• Initial Date Manufacturer Received: 01/09/2019
• Initial Date FDA Received: 01/29/2019
• Supplement Dates Manufacturer Received: 01/09/2019
• Supplement Dates FDA Received: 02/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other