MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) 22 G X .25 MM BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER INTRAVASCULAR CATHETER

Catalog Number 393222

Device Problem Fail-Safe Design Failure (1222)

Patient Problem Needle Stick/Puncture (2462)

Event Date 02/21/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(6). There is no 510(k) for this device as it is manufactured outside the us and not sold in the us. Results: the customer has indicated that samples are available for evaluation. However, prior to receiving samples the manufacturing site in (b)(4) completed a no sample investigation. As part of the investigation, a review of the device history record revealed no irregularities during the manufacture of the reported lot # 6203411. A manufacturing review revealed no abnormalities with preventative maintenance, calibration, or equipment that could have influenced the customer's reported issue. Conclusion: without a sample, an absolute root cause for this incident cannot be determined as bd was not able to duplicate or confirm the customer¿s indicated failure mode. In the event that samples are received, a new investigation will be completed and a supplemental report will be filed. (b)(4).

Event Description

It was reported that the safety mechanism of a 22 g x. 25 mm bd venflon¿ pro safety peripheral safety iv catheter with injection valve failed to function properly during a test in a clinical training department and the user suffered a needle stick injury. The needle did not come in contact with a patient, therefore the injury was from a clean needle. There was no report of medical intervention.

Manufacturer Narrative

Results: two used samples were returned for evaluation. Sample 1: a visual inspection revealed that the tether was detached from the needle hub. A microscopic inspection revealed that the heat stake post had no damage and measured within specification of 3. 5-4mm. The tether was observed to be deformed on the edges. The deformity was likely caused by stretching. Sample 2: a visual inspection revealed that the needle tip was not covered by the safety mechanism. A microscopic inspection revealed no damage to the v-clip. The catheter hub of this device was not returned for evaluation. A review of the device history record revealed no irregularities during the manufacture of the reported lot #6203411. A manufacturing review revealed no abnormalities with preventative maintenance, calibration, or equipment that could have influenced the customer's reported issue. Conclusion: although the returned samples exhibited defects, based on the device history record and manufacturing reviews, an absolute root cause for this incident cannot be determined. Remedial action required: although a root cause could not be determined, capa (b)(4) has been initiated to investigate needle stick injury related to this device.

• Brand Name: 22 G X .25 MM BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER
• Type of Device: INTRAVASCULAR 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: 6398204
• MDR Text Key: 70014082
• Report Number: 8041187-2017-00026
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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

• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/31/2019
• Device Catalogue Number: 393222
• Device Lot Number: 6203411
• Was Device Available for Evaluation?: No Answer Provided
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/21/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 82497

Patient Treatment Data

Date Received: 03/12/2017 Patient Sequence Number: 1