MAUDE Adverse Event Report: BECTON DICKINSON BD PEGASUS BL 22GA X 1.00IN PRN; INTRAVASCULAR CATHETER

Catalog Number 383731

Device Problem Packaging Problem (3007)

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

Event Date 03/28/2024

Event Type  malfunction  

Manufacturer Narrative

H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

Event Description

It was reported that bd pegasus bl 22ga x 1.00in prn package was damaged/defective the following information was provided by the initial reporter: it was found that the packaging of the whole box of feima products was damaged.The customer opened two boxes of the products and found that all nine feima products had holes in the packaging in the upper right corner.It was found that the packaging of the whole box of feima products was damaged.The customer after unpacking two boxes of products, i found that all nine pegasus bottles had holes in the packaging in the upper right corner.

Event Description

It was found that the packaging of the whole box of feima products was damaged.The customer opened two boxes of the products and found that all nine feima products had holes in the packaging in the upper right corner.It was found that the packaging of the whole box of feima products was damaged.The customer after unpacking two boxes of products, i found that all nine pegasus bottles had holes in the packaging in the upper right corner.

Manufacturer Narrative

2 photos were received for this complaint.Both photos show a pegasus sample with its needle cover protruding out of the corner of the blister packaging.There are no severe dents or crushed packaging observed on the samples seen in the photo.From the photo investigation, there is almost no dent on crush on the samples.If there is a damaged cause by the machine, the blister packaging will likely be crushed.There was no reporting of faulty robot or machine conveyor during the production of this batch.4 samples were received for this complaint.All 4 have the top right corners torn at the bending area of the blister packaging.The forming area looks badly dented but could be caused by the container that the samples were returned in.The bottom web thickness, sealing width & packaging seal strength of the 4 returned samples were inspected.All the inspected data for bottom web thickness were within the specification of 0.0254mm min.All the inspected data for seal width were within the specification of 3.0mm min.All the inspected data for the packaging seal strength were within the specification of 4.50 ¿ 17.80mm.Sample 2 from the returned sample was sent for ftir along with a current production bottom web.The ftir results shows both materials were analyzed as polyethylene.Both material was equivalent to each other.There was a qn raised for loose prn and slide clamp for this batch.The batch was manually sorted, batch was released after re-audit has passed.If there was a torn blister packaging, it will likely be easily noticeable during the sorting and a qn will raise for damaged packaging.The sorting is done manually by man and no machine is involved in the sorting.According to the verbatim, there were 9 samples found by the customer.The email attached mentions that customer found 4 in one box and another box has 5 samples.Only 4 of the samples will be returned for investigation, the rest of the 5 samples will not be returned and investigated.From the email, the shelf cartons will not be returned for further investigation.There are no similar complaint on this complaint batch #3113663.From the above investigation, the root cause of the damaged blister packaging cannot be determined.The complaint trend will be tracked and monitored.

• Brand Name: BD PEGASUS BL 22GA X 1.00IN PRN
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19169877
• MDR Text Key: 341612568
• Report Number: 2243072-2024-00562
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903837311
• UDI-Public: (01)00382903837311
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/17/2024

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: 383731
• Device Lot Number: 3113663
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/29/2024
• Initial Date FDA Received: 04/24/2024
• Supplement Dates Manufacturer Received: 05/17/2024
• Supplement Dates FDA Received: 05/20/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1