MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	368656
Medical Device Problem Codes	Product Quality Problem (1506); Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device type: fmi/jka.The customer's address is unknown: (b)(6), usa has been used as a default.
Event or Problem Description
It was reported that separation occurred during use with a bd vacutainer® push button blood collection set with pre-attached holder.The following information was provided by the initial reporter, "it was reported the device fell apart after use when button was pushed to retract the needle and left the needle unprotected.".
Event or Problem Description
It was reported that separation occurred during use with a bd vacutainer® push button blood collection set with pre-attached holder.The following information was provided by the initial reporter, "it was reported the device fell apart after use when button was pushed to retract the needle and left the needle unprotected.".
Additional Manufacturer Narrative
H.6.Investigation: as of august 2, 2019 this complaint is under the scope of field action # pas-19-1567: bd had not received samples or photos from the customer facility for evaluation; therefore, the investigation was limited.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.Bd has initiated further investigation relating to this issue through capa#982194 and potential causes have been identified.As a result, corrective actions have been established and are in the process of being implemented.H3 other text : see h.10.
Additional Manufacturer Narrative
E.4.Fda notified: the initial reporter also notified the fda on (07/11/2019) via medwatch # mw5087780.
Event or Problem Description
It was reported that separation occurred during use with a bd vacutainer® push button blood collection set with pre-attached holder.The following information was provided by the initial reporter, "it was reported the device fell apart after use when button was pushed to retract the needle and left the needle unprotected.".

• Brand Name: BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• MDR Report Key: 8884648
• Report Number: 1024879-2019-01408
• Device Sequence Number: 3294471
• Product Code: FMI
• UDI-Device Identifier: 50382903686563
• UDI-Public: 50382903686563
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K011984
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/27/2019

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: 03/31/2021
• Device Catalogue Number: 368656
• Device Lot Number: 9091626
• Initial Date Received by Manufacturer: 07/19/2019
• Supplement Date Received by Manufacturer: 07/19/2019; 07/19/2019
• Initial Report FDA Received Date: 08/12/2019
• Supplement Report FDA Received Date: 08/12/2019; 08/27/2019
• 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