MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) 22 G X 1.00 IN. BD INSYTE¿ PERIPHERAL VENOUS CATHETER

Catalog Number 381223

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

Patient Problems Ulceration (2116); Reaction (2414)

Event Date 09/08/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient developed an open ulcerative wound to right cephalic at the site of catheter insertion. The site was cultured with no growth noted. The wound was treated with "clip/clean" and bandages. There is no follow up from the patient's owner. The customer is unsure if the patient is reacting to the catheter material.

Manufacturer Narrative

Additional information: the actual device used in this incident is unknown. However, the customer returned samples from the following potential lot numbers: lot 2355422 - expiration date: 12/31/2017, manufacture date: 12/20/2012. Lot 5048489 - expiration date: 02/29/2020, manufacture date: 02/17/2015. Device evaluation: result - two unopened samples were returned for evaluation, one from lot 2355422 and one from lot 5048489. The returned samples were visually inspected. A cut was observed on the top web of the return samples. The sterility barrier of the returned samples could have possibly been compromised due to the cut. A process review was conducted and there is no process that could have resulted in the cut on the top web location. In addition, there is an inspection carried out after the packaging process and sharp objects are not used. Therefore, this nonconformance could have occurred out of the manufacturing facility. A review of the device history record was carried out and no abnormalities were found in the manufacture of the reported potential lot numbers. The sterility records were reviewed and no abnormality was observed. The preventive maintenance, calibration and equipment history records were reviewed and no abnormality was observed. Conclusion - an absolute root cause for this incident was not determined.

• Brand Name: 22 G X 1.00 IN. BD INSYTE¿ PERIPHERAL VENOUS CATHETER
• Type of Device: PERIPHERAL VENOUS CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 6004750
• MDR Text Key: 56765517
• Report Number: 8041187-2016-00063
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151698
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 10/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other Health Care Professional
• Device Catalogue Number: 381223
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No Answer Provided
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/13/2016
• 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

Patient Treatment Data

Date Received: 10/06/2016 Patient Sequence Number: 1