MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD VENFLON PRO SAFETY CATHETER; INTRAVENOUS CATHETER

Catalog Number 393224

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/16/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Date of event: unknown.The date received by manufacturer has been used for this field.Investigation summary: 1 sample was returned for the investigation of this complaint.Visual inspection, (b)(4) fitting inspection and luer taper measurement were conducted on the returned sample.The sample passed the acceptance criteria.Unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure mode.Dhr review: no device history record was reviewed as the batch number is unknown.Investigation conclusion: visual inspection, (b)(4) fitting inspection and luer taper measurement were conducted on the returned sample.The sample passed the acceptance criteria.Root cause description: visual inspection, (b)(4) fitting inspection and luer taper measurement were conducted on the returned sample.The sample passed the acceptance criteria.The probable root cause could be due lubricant migration to cannula hub which occur with age.The lubrication lowers the friction of interference fit between the luer taper and sarstedt adaptor and hence resulted in the disconnection.There is a capa (capa# (b)(4)) initiated for luer disconnection, but there is no information provided on the batch to determine if this batch is produce before or after the capa action implementation date.

Event Description

It was reported that the bd venflon pro safety catheter separated from the adapter causing spill of blood from the product.There was no exposure to blood.No serious injury or medical intervention noted.

• Brand Name: BD VENFLON PRO SAFETY CATHETER
• Type of Device: INTRAVENOUS CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7260240
• MDR Text Key: 100041885
• Report Number: 8041187-2018-00015
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 393224
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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): Other