MAUDE Adverse Event Report: BECTON DICKINSON BD VENFLON PRO; PERIPHERAL IV CATHETERS

Catalog Number 393204

Device Problem Packaging Problem (3007)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/12/2024

Event Type  malfunction  

Manufacturer Narrative

Address tab e.Too long: (b)(6).H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.

Event Description

It was reported that bd venflon pro package seal is compromised.The following information was provided by the initial reporter: customer found venflon pro packaging opened at bottom of cannula.Their customer found the packaging of the venflon pro were not sealed, appears plastic has hardened and pulled away from clear unit container.We had a similar incident ref# (b)(4).

Event Description

Customer found venflon pro packaging opened at bottom of cannula.K2 is a distributor for bd south africa.Their customer found the packaging of the venflon pro were not sealed, appears plastic has hardened and pulled away from clear unit container.We had a similar incident ref#(b)(4).

Manufacturer Narrative

04 photos were received by bd for evaluation.A quality engineer was able to review the photos of venflon pro 20g from lot # 2101138 regarding item #393204 with the reported issue that package seal integrity poor / questionable.The photos shows that the seal is open from the luer cap end of the catheter.One photo with 5 samples shows 5-unit packs with seal open, second photo show 4 samples with unit pack seal open again from luer cap side, third and fourth photo shows 1 sample each where seal is open from luer cap side of unit pack.The investigation was carried out on 25 retention samples where the investigating team has visually inspected the samples for package seal integrity and no poor / questionable package seal integrity was found in the 25 retention samples.The exact root cause can only be determined if we receive the original sample.

• Brand Name: BD VENFLON PRO
• Type of Device: PERIPHERAL IV CATHETERS
• 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18965494
• MDR Text Key: 338603112
• Report Number: 2243072-2024-00433
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903932047
• UDI-Public: (01)00382903932047
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: 505
• Type of Report: Initial,Followup
• Report Date: 05/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 393204
• Device Lot Number: 2101138
• Initial Date Manufacturer Received: 02/29/2024
• Initial Date FDA Received: 03/23/2024
• Supplement Dates Manufacturer Received: 05/15/2024
• Supplement Dates FDA Received: 05/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1