MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER PST GEL AND LITHIUM HEPARINN (LH) 65 UNITS BLOOD COLLECTION TUBE; BLOOD SPECIMEN COLLECTION DEVICE

Model Number	368056
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 0072540.Medical device expiration date: 2021-03-31.Device manufacture date: 2020-03-12.Medical device lot #: 0100294.Medical device expiration date: 2021-04-30.Device manufacture date: 2020-04-09.A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that foreign matter was discovered in tubes with a bd vacutainer® pst¿ gel and lithium heparinn (lh) 65 units blood collection tubes.This occurred with 2 tubes from lot# 0072540 prior to use, and 1 tube with lot# 0100294 after use.The following information was provided by the initial reporter: it is reported customer witnessed unknown foreign black matter in tubes; after and before use.
Event or Problem Description
It was reported that foreign matter was discovered in tubes with a bd vacutainer® pst¿ gel and lithium heparinn (lh) 65 units blood collection tubes.This occurred with 2 tubes from lot# 0072540 prior to use, and 1 tube with lot# 0100294 after use.The following information was provided by the initial reporter: it is reported customer witnessed unknown foreign black matter in tubes; after and before use.
Additional Manufacturer Narrative
H.6.Investigation: two customer samples from lot 0072540 and 2 photos were returned from the customer facility for evaluation.No samples were received from lot 0100294.The samples and photos do show the customer¿s failure mode of foreign matter.Based on a review of the device history record for the incident lot, 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.

• Brand Name: BD VACUTAINER PST GEL AND LITHIUM HEPARINN (LH) 65 UNITS BLOOD COLLECTION TUBE
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• MDR Report Key: 10532680
• Report Number: 1917413-2020-00814
• Device Sequence Number: 14110153
• Product Code: JKA
• UDI-Device Identifier: 50382903680561
• UDI-Public: 50382903680561
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 368056
• Device Catalogue Number: 367961
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2020
• Initial Date Received by Manufacturer: 08/24/2020
• Supplement Date Received by Manufacturer: 08/24/2020
• Initial Report FDA Received Date: 09/14/2020
• Supplement Report FDA Received Date: 10/12/2020
• 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