MAUDE Adverse Event Report: BECTON DICKINSON BD¿ TIP CAP TRAY; SYRING TIP CAP

Catalog Number	308341
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 7341762, expiration date: 2022-12-31, manufacture date:2018-01-16.Medical device lot #: 7356575, expiration date: 2022-12-31, manufacture date: 2018-02-22.Medical device lot #: 7361719, expiration date: 2023-01-31, manufacture date: 2018-02-06.Medical device lot #: 8039859, expiration date: 2023-02-28, manufacture date: 2018-03-14.
Event or Problem Description
It was reported that bd¿ tip cap trays have tip caps that will not stay on the iv syringes.There was no report of exposure, serious injury or medical intervention.
Additional Manufacturer Narrative
Investigation summary: a review of the device history record was completed for packaging lots 7341762, 7356575, 7361719 and 8039859.At the moment of this investigation no actual customer samples that present the reported issue have been provided for evaluation.Three unopened blister packages were received from the customer from each lot for evaluation.Each blister contains ten (10) tip caps.A total of thirty (30) tip caps per lot were visually and dimensionally evaluated per sb298 with acceptable results.Investigation conclusion: based on the investigation results to date, defect was not confirmed as actual customer samples with the reported condition were not provided for evaluation.Customer samples that were provided were evaluated with acceptable results.A review of the manufacturing records was performed for the incident lots and no manufacturing issues that could result in reported condition were observed.
Event or Problem Description
It was reported that bd¿ tip cap trays have tip caps that will not stay on the iv syringes.There was no report of exposure, serious injury or medical intervention.

• Brand Name: BD¿ TIP CAP TRAY
• Common Device Name: SYRING TIP CAP
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 7837363
• Report Number: 2618282-2018-00047
• Device Sequence Number: 13814221
• Product Code: KYW
• UDI-Device Identifier: 30382903083412
• UDI-Public: 30382903083412
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2018

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
• Operator of Device: Other
• Device Catalogue Number: 308341
• Device Lot Number: SEE H.10.
• Initial Date Received by Manufacturer: 08/10/2018
• Supplement Date Received by Manufacturer: 08/10/2018
• Initial Report FDA Received Date: 08/31/2018
• Supplement Report FDA Received Date: 10/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other