MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD¿ LUER TIP CAP STERILE TRAY; LIQUID MEDICATION DISPENSER

Catalog Number 305822

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 11/16/2018

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 #: 8149998.Medical device expiration date: 2023-05-31.Device manufacture date: 2018-05-29.Medical device lot #: 8087811.Medical device expiration date: 2023-03-31.Device manufacture date: 2018-03-28.(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¿ luer tip cap sterile tray has mold.No serious injury or medical intervention was reported.

Manufacturer Narrative

Investigation summary: no actual complaint samples were received.Representative samples were received and evaluated.The samples were a sealed cube of 4 shelf cartons (1000 ea x 4) from batch # 8149998 (p/n 305822).Each package with cap tips inside it within each carton was visually evaluated.No foreign matter, including mold, was found in any of the packages.All product was observed to be clean and absent of foreign matter.The reported defect was not identified in the samples received.A device history record review showed no rejected inspections or quality issues during the production of the two provided lot number(s) that could have contributed to the reported defect.

Event Description

It was reported that bd¿ luer tip cap sterile tray has mold.No serious injury or medical intervention was reported.

• Brand Name: BD¿ LUER TIP CAP STERILE TRAY
• Type of Device: LIQUID MEDICATION DISPENSER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8125214
• MDR Text Key: 129322618
• Report Number: 1213809-2018-00865
• 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: other,user facility
• Type of Report: Initial,Followup
• Report Date: 01/21/2019

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: 305822
• Device Lot Number: SEE H.10
• Initial Date Manufacturer Received: 11/16/2018
• Initial Date FDA Received: 12/03/2018
• Supplement Dates Manufacturer Received: 11/16/2018
• Supplement Dates FDA Received: 01/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other