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

Catalog Number	367285
Medical Device Problem Codes	Leak/Splash (1354); Volume Accuracy Problem (1675)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
For oem manufacturing sites: in this mdr, bd corporate headquarters in (b)(4) has been listed as (b)(4) is an oem manufacturing site.Date of event: unknown.The date received by manufacturer has been used for this field.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 tubing separated from the barrel and there was insufficient blood flow with a bd vacutainer® safety-lok¿ blood collection set.The tubes having insufficient blood flow occurred on 5 separate occasions during use, however, the date/time and or patient information is unknown.The following information was provided by the initial reporter: customer would like to report insufficient blood flow witnessed when using product 367285.Facility has experienced 5 occurrences of this issue as well as one issue of tubing separating completely from barrel.No specific date is known for any of these occurrences.No blood exposure, no medical intervention and no safety issue.
Additional Manufacturer Narrative
H.6.Investigation: bd received samples from the customer facility for investigation.The samples were tested/evaluated and the customer's indicated failure modes for insufficient blood flow and tubing separating from the barrel with the incident lot was not observed as all product specifications were met.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 tubing separated from the barrel and there was insufficient blood flow with a bd vacutainer® safety-lok¿ blood collection set.The tubes having insufficient blood flow occurred on 5 separate occasions during use, however, the date/time and or patient information is unknown.The following information was provided by the initial reporter: customer would like to report insufficient blood flow witnessed when using product 367285.Facility has experienced 5 occurrences of this issue as well as one issue of tubing separating completely from barrel.No specific date is known for any of these occurrences.No blood exposure, no medical intervention and no safety issue.

• 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: 9203027
• Report Number: 2243072-2019-02324
• Device Sequence Number: 2579244
• Product Code: JKA
• UDI-Device Identifier: 50382903672856
• UDI-Public: 50382903672856
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2019

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: Other
• Device Expiration Date: 04/30/2022
• Device Catalogue Number: 367285
• Device Lot Number: 9D2611
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2019
• Initial Date Received by Manufacturer: 10/02/2019
• Supplement Date Received by Manufacturer: 10/02/2019
• Initial Report FDA Received Date: 10/17/2019
• Supplement Report FDA Received Date: 11/05/2019
• 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