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

Catalog Number 305210

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 12/06/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.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 #: 8236735.Medical device expiration date: n/a.Device manufacture date: 2018-08-24.Medical device lot #: 8236730.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 gave erroneous results.No serious injury or medical intervention was reported.

Event Description

It was reported that bd¿¿ oral syringe with tip cap gave erroneous results.No serious injury or medical intervention was reported.

Manufacturer Narrative

Investigation summary: no samples have been returned for evaluation.However, material 305210, syringe oral 3ml amber is sold with the claim bulk non-sterile.Bd does not make a claim for the quantity of bioburden on this product.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot numbers that could have contributed to the reported defect.The reported defect was not 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: 8190286
• MDR Text Key: 131313021
• Report Number: 1213809-2018-00962
• 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: 01/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2018
• 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
• Date Manufacturer Received: 12/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other