MAUDE Adverse Event Report: BD CARIBE LTD. BD VACUTAINER® BLOOD TRANSFER DEVICE HOLDER; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	36488000
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use with the bd vacutainer® blood transfer device holder with female luer adapter, the sleeve came off.There was no report of patient impact.The following information was provided by the initial reporter, translated from japanese: the customer reported that the rubber sleeve on the np needle came off.The rubber sleeve came off during use.
Additional Manufacturer Narrative
D4.Medical device expiration date: unknown.H3.Investigation summary: bd juncos had not received samples or photos for evaluation.A dhr review and retain sample analysis could not be conducted as the complaint incident lot number was not available at the time of this evaluation.This evaluation will be updated if the incident lot number is received.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends.Based on the lack of information provided by the customer, the defect could not be confirmed.Bd juncos was not able to evaluate the customer¿s indicated failure mode via retain sample testing because the lot number is unknown.Per the investigation performed, current controls are adequate to mitigate risks associated to the reported failure.H4.Device manufacture date: unknown.H3 other text: see h10.

• Brand Name: BD VACUTAINER® BLOOD TRANSFER DEVICE HOLDER
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos IA
• Manufacturer (Section G): BD CARIBE LTD.; road 31; k.m. 24.3; juncos IA
• Manufacturer Contact: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17909531
• Report Number: 2618282-2023-00080
• Device Sequence Number: 7497328
• Product Code: JKA
• UDI-Device Identifier: 50382903648806
• UDI-Public: 50382903648806
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K991088
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/05/2023

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 Catalogue Number: 36488000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2023
• Initial Report FDA Received Date: 10/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Unknown