MAUDE Adverse Event Report: BECTON DICKINSON BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	367297
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device evaluated by mfr: a device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
Material no.: 367297.Batch/lot: 9a1381.It was reported that during use of the bd vacutainer® safety-lok¿ blood collection set leaked on the side of the hub.The following information was provided by the initial reporter: customer states that a 23g slbcs leaked on the side of the hub.It was attached to a syringe, no blood was allowed into the syringe according to the customer and had to restick patient.
Additional Manufacturer Narrative
H.6.Investigation summary: bd received samples and photos from the customer facility for investigation.The photos were evaluated and the customer's indicated failure mode for hub leakage with the incident lot was observed.However, returned and retention samples were selected from bd inventory for evaluation/testing and upon completion, no issues were observed relating to hub leakage as all samples met specifications.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.Investigation conclusion: based on evaluation of the customer photos, the customer¿s indicated failure mode for hub leakage with the incident lot was observed.Evaluation/testing of the customer samples was conducted and hub leakage was not observed.Additionally, evaluation/testing of the retain samples was conducted and hub leakage was not observed.Root cause description: based on the investigation, a root cause could not be determined.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.The bd business team regularly reviews the collected data for identification of emerging trends.H3 other text: see section h.10.
Event or Problem Description
Material no.: 367297.Batch/lot: 9a1381.It was reported that during use of the bd vacutainer® safety-lok¿ blood collection set leaked on the side of the hub.The following information was provided by the initial reporter: customer states that a 23g slbcs leaked on the side of the hub.It was attached to a syringe, no blood was allowed into the syringe according to the customer and had to re-stick patient.

• Brand Name: BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8793854
• Report Number: 2243072-2019-01423
• Device Sequence Number: 2838376
• Product Code: JKA
• UDI-Device Identifier: 50382903672979
• UDI-Public: 50382903672979
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K991088
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2019

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: Health Professional
• Device Expiration Date: 01/31/2012
• Device Catalogue Number: 367297
• Device Lot Number: 9A1381
• Initial Date Received by Manufacturer: 07/01/2019
• Supplement Date Received by Manufacturer: 07/01/2019
• Initial Report FDA Received Date: 07/16/2019
• Supplement Report FDA Received Date: 08/05/2019
• 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