MAUDE Adverse Event Report: BD (SUZHOU) BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM INTRAVENOUS CATHETER

Catalog Number 383914

Device Problem Fail-Safe Design Failure (1222)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/18/2017

Event Type  malfunction  

Manufacturer Narrative

Customer stated that the shield activation failed when the needle was withdrawn from the patient. A sample was provided by the customer and investigated by the quality engineer. It was found that the v-clip was deformed and would not assemble with the catheter adapter successfully. Current assembly process from the pegasus auto line only checks the presence before assembling which we found the washer can pop out at the low probability. The production record was reviewed and no non-conformance was noted during the manufacturing of this lot related to complaint issue. Conclusion: the root cause for this incident was determined to be a deformed v-clip.

Manufacturer Narrative

Initial reporter phone#: (b)(6). Pma / 510(k) #: there is no 510(k) for this device as it is manufactured outside the us and not sold in the us. 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 during use of the bd pegasus¿ safety closed iv catheter system the nurse successfully advanced the catheter, however when the nurse withdrew the needle the shield activation failed. There was no report of injury or medical intervention.

• Brand Name: BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM
• Type of Device: INTRAVENOUS 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: 6942219
• MDR Text Key: 251199350
• Report Number: 3006948883-2017-00076
• 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

• Type of Report: Initial,Followup
• Report Date: 10/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 03/31/2020
• Device Catalogue Number: 383914
• Device Lot Number: 7095216
• Was Device Available for Evaluation?: No Answer Provided
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/18/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/05/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 10/11/2017 Patient Sequence Number: 1