MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER® EST Z (NO ADDITIVE) PLUS BLOOD COLLECTION TUBES

Catalog Number	362725
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event awareness date used.(b)(6).Bd had not received samples or photos from the customer facility for evaluation; therefore, the investigation was limited.A review of the manufacturing records was completed for the incident lot and no issues were identified.
Event or Problem Description
It was reported that bd vacutainer® est z (no additive) plus blood collection tube cap not conforming the stopper pops out.
Additional Manufacturer Narrative
Pma / 510(k)# changed from "n/a" to "exempt".

• Brand Name: BD VACUTAINER® EST Z (NO ADDITIVE) PLUS BLOOD COLLECTION TUBES
• Common Device Name: BD VACUTAINER® EST Z (NO ADDITIVE) PLUS BLOOD COLLECTION TUBES
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth
• MDR Report Key: 7480651
• Report Number: 9617032-2018-02347
• Device Sequence Number: 105442
• Product Code: JKA
• UDI-Device Identifier: 50382903627252
• UDI-Public: 50382903627252
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2018

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 Expiration Date: 09/30/2018
• Device Catalogue Number: 362725
• Device Lot Number: 7087946
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/22/2017
• Supplement Date Received by Manufacturer: 08/22/2017
• Initial Report FDA Received Date: 05/02/2018
• Supplement Report FDA Received Date: 05/31/2018
• 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