MAUDE Adverse Event Report: BECTON DICKINSON BD VENFLON¿ IV CANNULA 20G X 1 IN. INTRAVASCULAR CATHETER

Catalog Number 391492

Device Problems Break (1069); Detachment Of Device Component (1104); Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/21/2017

Event Type  Injury  

Manufacturer Narrative

Medical device expiration date: unknown. (b)(6). Device manufacture date: unknown. Investigation summary: bd (b)(6) received 1 photo from the customer facility for investigation. (b)(4) retention samples of lot# 17h2941m had been visually inspected, for any defect on catheter, all samples found in good condition. The complaint history for the lot# 17h2941m was reviewed and till date no complaint had been registered against the above lot for the defect ¿ damaged component /product. Dhr was reviewed for the product test. The entire routing test for reported lot found within the specification limit. No ncp for damaged component /product was reported and recorded in dhr in customer reported lot # 17h2941m. Log sheet ¿ station# (b)(4) picking problem is recorded in primary packaging process (ra assembly) during manufacturing of lot # ra68h311, ra68h312, ra68h313, ra68h301, ra68h302 & ra68h303. Stoppages ¿ the ptfe tube from batches (b)(4) are used in the manufacturing of lot # 17h2941m. No defect found in the ptfe tube for the batches consumed in the manufacturing lot# 17h2941m. Investigation conclusion: confirmed: bd was able to duplicate or confirm the customers¿ indicated failure mode customer returned photo showed the evidence of damaged component /product (catheter). Root cause description: the team reviewed the process controls of assembly process and packaging process. All process controls are in place. The team also checked the catheter pull force pull force of lot# 17h2941m & within the specification limit of minimum 15n. In description of complaint it is mentioned that at the time of dressing (tegaderm) the catheter was found broken. This indicates that there are chances that due to practice issue (during dressing) the catheter got broken / cut from the catheter adaptor. Also, some part of the ptfe tube can be seen in the photograph shared by the customer. Due to unavailability of defective sample further investigation could not be done. The team will monitor the defect during manufacturing and if any such incidence occur related to catheter damage or broken will take actions appropriately. The exact root cause is not identified.

Event Description

It was reported that during use, a bd venflon¿ iv cannula malfunctioned as the cannula broke from the hub of the shaft. The cannula remained in the vein. Medical intervention was required. The patient was transferred to (b)(6) hospital where a mri was performed. The cannula shaft was relocated during observation of mri but still remained in patient. Surgery was required and performed on the patient to remove the shaft.

• Brand Name: BD VENFLON¿ IV CANNULA 20G X 1 IN.
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7060589
• MDR Text Key: 92986053
• Report Number: 2243072-2017-00223
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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
• Report Date: 10/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 391492
• Device Lot Number: 17H2941M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2017
• 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: 11/27/2017 Patient Sequence Number: 1