MAUDE Adverse Event Report: BD (SUZHOU) BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM, 20 G X 1.16 IN.; INTRAVASULAR CATHETER

Catalog Number 383742

Device Problem Fail-Safe Design Failure (1222)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/01/2016

Event Type  malfunction  

Manufacturer Narrative

Pma / 510(k) #: there is no 510(k) for this device as it is manufactured outside the us and not sold in the us.(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that the safety mechanism failed to activate after puncture with a bd pegasus¿ safety closed iv catheter system, 20 g x 1.16 in.There was no report of injury or medical intervention.

Manufacturer Narrative

Device manufacture date: 08/08/2015-08/21/2015.Device evaluation: results: one used sample was returned for evaluation.A visual inspection revealed the tip shield was not activated and was connected to the catheter adapter.The v-clip in the tip shield was tilted.As part of a simulated use test, the v-clip was lightly touched to reset it and the safety mechanism was then successfully activated.A review of the device history record revealed no irregularities during the manufacture of the reported lot # 5299015.A manufacturing review revealed no abnormalities in the incoming material, assembly process, or packaging process.Conclusion: although the customer's indicated failure mode was observed, an absolute root cause for this incident cannot be determined.Our quality engineer notes that a probable cause for this incident is tilted v-clips causing the tip shield to stick and not activate.Employees will be trained not to squeeze transfer boxes in the production process, v-clip assembly operators will be notified to not touch tip shields, and design improvement will be discussed with r and d.

• Brand Name: BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM, 20 G X 1.16 IN.
• Type of Device: INTRAVASULAR 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 ; 8015652845
• MDR Report Key: 6202061
• MDR Text Key: 63610175
• Report Number: 3006948883-2016-00038
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: 383742
• Device Lot Number: 5299015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2016
• 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