MAUDE Adverse Event Report: BD (SUZHOU) BD PEGASUS BL 22GA X 1.00IN QSYTE; INTRAVASCULAR CATHETER

Catalog Number 383933

Device Problem Delivered as Unsterile Product (1421)

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

Event Date 05/13/2019

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone #: unknown.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 that package was open with a bd pegasus bl 22ga x 1.00in qsyte.The following information was provided by the initial reporter, translated from (b)(6) to english: it's found that the single unit package was broken when getting the product out of the shelf box.The catheter was tilted, which cannot be used.

Event Description

It was reported that package was open with a bd pegasus bl 22ga x 1.00in qsyte.The following information was provided by the initial reporter, translated from chinese to english: it's found that the single unit package was broken when getting the product out of the shelf box.The catheter was tilted, which cannot be used.

Manufacturer Narrative

H.6.Investigation summary: a device history review was conducted for lot number 6231326.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.Although photos were submitted for evaluation, they did not display the failure mode clearly enough to identify the root cause; unfortunately without the ability to inspect the affected unit, the root cause for this complaint could not be determined at the conclusion of our review.

• Brand Name: BD PEGASUS BL 22GA X 1.00IN QSYTE
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• MDR Report Key: 8668548
• MDR Text Key: 147049703
• Report Number: 3006948883-2019-00431
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: PENDING
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 07/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/31/2019
• Device Catalogue Number: 383933
• Device Lot Number: 6231326
• Date Manufacturer Received: 05/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other