MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD SEDITAINER¿ 0.105M 1.25ML BUFFERED SODIUM CITRATE BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	366065
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that during r&d testing at bd, a glass tube was found to be broken upon receipt with a bd seditainer¿ 0.105 m 1.25 ml buffered sodium citrate blood collection tubes.The following information was provided by the initial reporter: during r&d testing in, we observed a glass tube that was received as cracked/broken at the tube top (underneath the hemogard¿ closure).
Additional Manufacturer Narrative
H.6.Investigation: bd received samples from the customer facility for investigation.The samples were evaluated and the customer's indicated failure mode for tube damage with the incident lot was observed.Additionally, retention samples were selected from bd inventory for evaluation and upon completion, the issue relating to tube damage was observed.A review of the device history record was completed for the incident lot and, based on this review, all product specifications and requirements for lot release were met; there were no related quality non-conformances during manufacturing of the product.H3 other text : see h.10.
Event or Problem Description
It was reported that during r&d testing at bd, a glass tube was found to be broken upon receipt with a bd seditainer¿ 0.105m 1.25ml buffered sodium citrate blood collection tubes.The following information was provided by the initial reporter: during r&d testing in, we observed a glass tube that was received as cracked/broken at the tube top (underneath the hemogard¿ closure).

• Brand Name: BD SEDITAINER¿ 0.105M 1.25ML BUFFERED SODIUM CITRATE BLOOD COLLECTION TUBES
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• MDR Report Key: 8921643
• Report Number: 9617032-2019-00964
• Device Sequence Number: 16656162
• Product Code: JKA
• UDI-Device Identifier: 50382903660655
• UDI-Public: 50382903660655
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K953994
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2019

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
• Operator of Device: Other
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: 366065
• Device Lot Number: 9171567
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2019
• Initial Date Received by Manufacturer: 08/06/2019
• Supplement Date Received by Manufacturer: 08/06/2019
• Initial Report FDA Received Date: 08/22/2019
• Supplement Report FDA Received Date: 09/05/2019
• 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