MAUDE Adverse Event Report: BD (SUZHOU) PEGASUS PNK 20GAX1.16IN PRN-CAPY NON-PVC; INTRAVASCULAR CATHETER

Catalog Number 383746

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Inflammation (1932)

Event Date 08/14/2020

Event Type  Injury  

Manufacturer Narrative

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 patient developed an allergic reaction during use with the pegasus pnk 20gax1.16in prn-capy non-pvc catheter.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter, translated from (b)(6) to english: "after the puncture by the nurse, the patient showed allergic phenomenon of honeycomb macula on the forearm of one hand, and immediately pulled out the indwelling needle and showed allergic phenomenon after the puncture on the back of the other hand.The second patient showed allergic phenomenon in the eyes and face after the puncture.On (b)(6) 2020, based on the confirmation of the local associate, two patient were affected, detail patient information is unknown.".

Event Description

It was reported that the patient developed an allergic reaction during use with the pegasus pnk 20gax1.16in prn-capy non-pvc catheter.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter, translated from (b)(6) to english: "after the puncture by the nurse, the patient showed allergic phenomenon of honeycomb macula on the forearm of one hand, and immediately pulled out the indwelling needle and showed allergic phenomenon after the puncture on the back of the other hand.The second patient showed allergic phenomenon in the eyes and face after the puncture.2020/10/06 based on the confirmation of the local associate, two patient were affected, detail patient infomation is unknown.".

Manufacturer Narrative

Investigation summary: a device history review was conducted for lot number 9316664.Our records show that this is the only instance of this issue occurring in this production batch.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.Additionally, his lot was treated and received a certificate of conformance for sterility.Unfortunately, without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.

• Brand Name: PEGASUS PNK 20GAX1.16IN PRN-CAPY NON-PVC
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• MDR Report Key: 10744401
• MDR Text Key: 213388071
• Report Number: 3006948883-2020-00622
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 11/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2023
• Device Catalogue Number: 383746
• Device Lot Number: 9316664
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other