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

Catalog Number 305210

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 12/07/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: n/a.(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 foreign matter on the tip of the syringe.No serious injury or medical intervention was reported.

Manufacturer Narrative

H.6.Investigation summary: three photos and one physical sample were received for evaluation.The sample was the same syringe depicted in the photos and was visually evaluated.The sample was a loose 3ml amber oral assembled syringe.The barrel was found to have damaged tip on one side and slight damage to the roof of the barrel on the same side.In the areas where there was damage a white powdery substance: a type of residue: appeared to remain.The residue appeared to be the remains of a once liquid substance as it was ¿streaking¿ down the side of the tip and was also observed farther down the same side of the barrel where there was no damage.Based on the fourier transform infrared results, the foreign matter was not part of the syringe manufacturing process and was likely introduced to the product at some point after it had left the manufacturing plant.Although it is possible the damage to the barrel occurred during the assembly process, it is difficult to definitively state so due to the sample having been contaminated and manipulated after leaving the plant.It is also possible the damage was introduced at some point during the sample¿s manipulation.The reported defect was not identified in the samples received.Furthermore, 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 foreign matter on the tip of the syringe.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: 8196410
• MDR Text Key: 131482948
• Report Number: 1213809-2018-00924
• 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: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 01/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 305210
• Device Lot Number: 8236729
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2018
• Date Manufacturer Received: 12/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other