MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD VENFLON PRO SAFETY 20GA INDIA; INTRAVASCULAR CATHETER

Catalog Number 393244

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Erythema (1840); Pain (1994); Swelling/ Edema (4577)

Event Date 08/18/2022

Event Type  malfunction  

Event Description

It was reported while using bd venflon pro safety 20ga india the product was found to be non sterile and damaged.There was no report of patient impact.The following information was provided by the initial reporter: according to the investigation summary: "the returned samples were subjected to visual inspection.The unit package of the five samples were package.The top web was found to be torn on two of the unit packs.The product in the unit pack was also found to be damaged." description of the event/incident: verbatim: ¿venflon pro safety cannulas are getting replaced after every 5-6 hours due to patient complaints suffering from severe pain with no sign and symptoms of redness and swelling in some patients and in some patients redness and sweeling can be seen.¿.

Manufacturer Narrative

Five representative samples were received by our quality team for evaluation.The returned samples were subjected to visual inspection.The unit package of the five samples were package.The top web was found to be torn on two of the unit packs.The product in the unit pack was also found to be damaged.The bottom web seal was subjected to visual inspection.A grid mark was observed on the bottom web.This shows that the sealing process was completed, and the seal width was within specification.A review of the internal manufacturing device records and raw material history files for the reported lot number was performed and no recorded quality problems or rejections to this incident were found.The sterilization records were reviewed, and no abnormalities were observed.Based on the damage observed, the unit pack was likely subjected to an external force being applied.The manufacturing process was reviewed.There is no process in the manufacturing that would cause the damage to the unit package and product.There was no abnormality during the production of the reported batch.Therefore, the damage observed could have occurred out of the manufacturing facility.The probable root cause for irritation / inflammation could be due to an incorrect aseptic technique during product application or the user using a product with a damaged package where the sterility of the product was compromised.However, as it is not possible to confirm the condition of the product when it was used, the root cause could not be confirmed.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD VENFLON PRO SAFETY 20GA INDIA
• Type of Device: INTRAVASCULAR 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15556955
• MDR Text Key: 305981516
• Report Number: 8041187-2022-00579
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 393244
• Device Lot Number: 1359707
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1