MAUDE Adverse Event Report: BD (SUZHOU) UNSPECIFIED BD¿ CATHETER

Catalog Number UNKNOWN

Device Problem Device Slipped (1584)

Patient Problem Needle Stick/Puncture (2462)

Event Date 05/04/2019

Event Type  Injury  

Manufacturer Narrative

Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: unfortunately, a valid lot number and physical sample could not be obtained for the purpose of aiding in our investigation.As a result, bd engineers were unable to identify a root cause or trending data regarding this event.Bd will continue to track and trend for this issue investigation conclusion: lot number could not be validated using sap.

Event Description

It was reported that unspecified bd¿ catheter needle slipped out during usage and caused a needle stick injury.The following information was provided by the initial reporter: the needle slipped out during the usage, which caused stick injury.The injury was treated immediately by using mupirocin ointment.The patient's injury recovered.

• Brand Name: UNSPECIFIED BD¿ CATHETER
• Type of Device: CATHETER
• Manufacturer (Section D): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• Manufacturer (Section G): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 8671868
• MDR Text Key: 147096514
• Report Number: 3006948883-2019-00436
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: UNKNOWN
• Device Lot Number: 8141415
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/22/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention