MAUDE Adverse Event Report: BD (SUZHOU) PEGASUS PNK 20GA X 1.16IN QSYTE-CAP INTRAVENOUS CATHETER

Catalog Number 383944

Device Problems Device Operates Differently Than Expected (2913); Fail-Safe Problem (2936)

Patient Problem Needle Stick/Puncture (2462)

Event Date 10/10/2017

Event Type  malfunction  

Manufacturer Narrative

Sample was returned and decontaminated. Returned sample showed the tip shield are separated with cannula. The exposed cannula v-clip didn't activate. There is a missing washer, which resulted in the cannula being exposed. There is a missing washer, which caused the cannula to be directly exposed to the customer. The washer is manually assembled, the operator will conduct a visual inspection. Root cause: the root cause is the missing washer which caused the cannula to be exposed. Manufacturing inspection: after reviewing dhr, no abnormality was found in in-coming inspection, whole assembly process and qa inspection. Bd was able to confirm the customer's indicated failure mode.

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.

Event Description

It was reported during use of the pegasus pnk 20ga x 1. 16in qsyte-cap nurse found safety shield activation failed when withdrawing needle. The nurse received needle stick. There was no report of injury or medical intervention.

• Brand Name: PEGASUS PNK 20GA X 1.16IN QSYTE-CAP
• 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: 6999822
• MDR Text Key: 252914219
• Report Number: 3006948883-2017-00084
• 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: 11/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/30/2018
• Device Catalogue Number: 383944
• Device Lot Number: 5296195
• 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: 10/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/23/2015
• 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: 11/03/2017 Patient Sequence Number: 1