MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) SEE H.10; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	367964
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device brand name: bd vacutainer® pst¿ gel and lithium heparin (lh) 126 units blood collection tubes a device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd vacutainer® pst¿ gel and lithium heparin (lh) 126 units blood collection tube experienced missing component of product which was noted prior to use.The following information was provided by the initial reporter: material no.367964 batch no.9095794.Per email: during r&d testing, one tube was found in the shelf pack that did not have a stopper.The product information is: catalog # - 367964.Batch # - 9095794.Test date ¿ 4 oct 2019.
Additional Manufacturer Narrative
The following information has been corrected: h.6 investigation summary: 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.E.6.Method codes: 3331, 4114.E.6.Result codes: 3221.Conclusion codes: 67.H3 other text.
Event or Problem Description
It was reported that the bd vacutainer® pst¿ gel and lithium heparin (lh) 126 units blood collection tube experienced missing component of product which was noted prior to use.The following information was provided by the initial reporter: material no.367964.Batch no.9095794.Per email: during r&d testing, one tube was found in the shelf pack that did not have a stopper.The product information is: catalog # - 367964, batch # - 9095794, test date ¿ 4 oct 2019.

• Brand Name: SEE H.10
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• Manufacturer (Section G): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 9213907
• Report Number: 1917413-2019-02225
• Device Sequence Number: 2751664
• Product Code: JKA
• UDI-Device Identifier: 50382903679640
• UDI-Public: 50382903679640
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K945952
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2019

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: 04/30/2020
• Device Catalogue Number: 367964
• Device Lot Number: 9095794
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 10/04/2019
• Supplement Date Received by Manufacturer: 10/04/2019
• Initial Report FDA Received Date: 10/21/2019
• Supplement Report FDA Received Date: 10/21/2019
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown