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

Catalog Number 383711

Device Problems Component Missing (2306); Device Operates Differently Than Expected (2913)

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

Event Date 12/02/2017

Event Type  Injury  

Manufacturer Narrative

Results: bd received one sample from the customer in support of this complaint. The failure mode was observed in the sample provided by the customer, and no additional abnormalities in the incoming material, assembly process or packaging process were observed in the batch record. The indwelling needle was being used for 4 days (b)(6) it was fine for the first 3 and failed on the fourth. Because the unit behaved normally for the first three days it was determined to be within specification. (b)(4) cannot finalize the root cause of the plant as a result. A review of the device history record revealed no irregularities during the manufacture of the reported lot number. Conclusion: in conclusion, based on the current investigation, no abnormality was found at the beginning of using. (b)(4) plant can't finalize the root cause for this kind of failure.

Manufacturer Narrative

Medical device lot #: 7083015, medical device expiration date: 3/31/2020, device manufacture date: 3/24/2017. Medical device lot #: 7110497, medical device expiration date: 4/30/2020, device manufacture date: 4/20/2017. 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 on day two of using the bd pegasus¿ safety closed iv catheter system it malfunctioned as the catheter was found with the ¿indwelling portion missing from the root of the tube. ¿ medical intervention was needed and an x- ray was performed. It is unknown what further medical intervention was given.

• Brand Name: BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM
• Type of Device: INTRAVASCULAR 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: 7144115
• MDR Text Key: 116936397
• Report Number: 3006948883-2017-00188
• 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: 01/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 383711
• Device Lot Number: SEE H.10.
• 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: 12/04/2017
• 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 Treatment Data

Date Received: 12/22/2017 Patient Sequence Number: 1