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

Catalog Number 393204

Device Problem Unsealed Device Packaging (1444)

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

Event Date 09/11/2023

Event Type  malfunction  

Manufacturer Narrative

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 packed sleeves open at the seal which renders these venflon needles unsterile.

Manufacturer Narrative

4 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.Customer provided photograph review: 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 defect of seal open/deformed packaging/packaging damage can be confirmed based on the photographs provided by the customer.Retention sample review: 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 defect of seal open/deformed packaging/packaging damage cannot be confirmed based on the investigation of the retention samples.

Event Description

Material #: 393204 batch#: 2101138.It was reported by customer that they found packed sleeves open at the seal which renders these venflon needles unsterile.Verbatim: rcc received a complaint via email.Email(s) attached customer found packed sleeves open at the seal which renders these venflon needles unsterile bd (product code: 393204).2101138 (exp date: 25.04.02).Customer response for follow-up: 1.Please provide the date of event.09/11/2023 (complaint reported to us on the 12/02/2024).2.Kindly share the exact address details to send a return shipping label.106 16th road midrand johannesburg, south africa.3.Any physical sample available for investigation? yes.4.Did the event directly, or indirectly involve a patient or user? indirectly involve(not used by patient).5.Has there been any patient impact (serious injury, medical intervention, change of treatment required)? no.6.Please confirm the number of occurrences.74.

• 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: 18967442
• MDR Text Key: 338673360
• Report Number: 2243072-2024-00435
• 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,Distributor
• Reporter Occupation: 505
• Type of Report: Initial
• Report Date: 03/04/2024

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: Health Professional
• Device Catalogue Number: 393204
• Device Lot Number: 2101138
• Initial Date Manufacturer Received: 02/29/2024
• Initial Date FDA Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1