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 11/01/2018

Event Type  malfunction  

Manufacturer Narrative

The date received by manufacturer has been used for this field.Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 8120501, medical device expiration date: n/a, device manufacture date: 2018-04-30.Medical device lot #: 8236730, medical device expiration date: n/a, device manufacture date: 2018-08-24.Medical device lot #: 8236729, medical device expiration date: n/a, device manufacture date: 2018-08-24.(b)(6).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that bd¿ oral syringe with tip cap had a damaged plunger.No serious injury or medical intervention was reported.

Manufacturer Narrative

Multiple photos were received and evaluated.The photos depict 3ml amber oral syringes filled with medication, inside bags and loose on table.Several syringes have plunger rods with broken or cracked ribs.The rib damage varies between the individual syringes in photos from severe to moderate.The damage observed is a rejectable defect per product specification.Most of the syringes inside the bags in the photos appear to have intact plunger rod ribs.The defect appears to not affect every sample.Machine logs reveal that assembly dial jams were recorded during the manufacture of the sub-assembly that was consumed by the packaging batch 8236730.Plunger feeding rail was found to be too wide causing plunger feed issues.Records indicate technician intervention was required for the above issues.The potential root cause for the broken plunger rod is likely due to improper setup of the rail gap.The setup would cause improper feeding of the plunger rods and result in the component to assembly dial misalignment.This, in turn, could result in the damage observed.The root cause was addressed when it was discovered during the manufacture of the subassembly batch on (b)(6) 2018.The technician involved is no longer assigned to this assembly line.The technician involved will be provided additional training to enhance troubleshooting skills.Due date: (b)(6) 2019.Additionally, preventive maintenance plan is in place to inspect and adjust sensors, alignment, clearance, among other items on the plunger rail and the assembly dial.The aql for incorrect assembly is 0.65%.Defective rate identified is 265 out of 360,000, which is 0.074%.Customer defective rate from product received is 265 out of 267,470, which is 0.099%.Customer defective rate from product inspected 265 out of 58,692, which is 0.45%.The defective rates identified are within the acceptable quality limits.No additional actions are required based on the investigation performed.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.

Event Description

It was reported that bd oral syringe with tip cap had a damaged plunger.No serious injury or medical intervention was reported.

• 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: 8061342
• MDR Text Key: 127074279
• Report Number: 1213809-2018-00821
• 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: 11/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2018
• 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
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other