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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) 18 G X .32 MM BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER INTRAVASCULAR CATHETER

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BECTON DICKINSON MEDICAL (SINGAPORE) 18 G X .32 MM BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 393226
Device Problems Unsealed Device Packaging (1444); Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/17/2017
Event Type  malfunction  
Manufacturer Narrative
Initial reporter phone #: (b)(6). Results: investigation summary: six actual samples were returned for the investigation of this complaint. The bottom web of the unit package had shrunk and become deformed near the end cap area of the vps part causing it to be force opened at the opening tab. Deformed package with open seal. Visual inspection was performed on the sealing features of the returned samples. Grid mark was observed on the bottom web. This shows that sealing process has been completed and the seal width is within specification. Grid mark on bottom web. The bottom web material had melted and it took the shape of the product, thereby causing the package to be forced opened and left an opened seal at the opening tab area. Visual inspection was performed on the returned unit package. Grid mark was observed on the bottom web. This shows that sealing process has been completed and the seal width is within specification. There is no process in the manufacturing facility that could cause this nonconformance. There was 100% sorting done on sterile parts for this affected batch prior to shipment. Based on the above investigation result, the reported nonconformance occurred after the product was packed in our manufacturing and sterilization process. Therefore, the probable root cause could be due to temperature gradient experience by the product during handling (transportation, storage, loading and unloading, etc. ) the lot master for batch# 7207496 (catalog #393226) was reviewed. No quality notifications were raised for the vps batch. No abnormalities were observed after reviewing preventative maintenance, calibration and equipment. All sealing process parameter were within validated range.
 
Event Description
It was reported that the packagings of some 18 g x. 32 mm bd venflon¿ pro safety peripheral safety iv catheters were found open breaking the sterile barrier. There was no report of injury or medical intervention.
 
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Brand Name18 G X .32 MM BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER
Type of DeviceINTRAVASCULAR 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
brett wilko
9450 south state street
sandy, UT 84070
8015652845
MDR Report Key7012087
MDR Text Key92507375
Report Number8041187-2017-00155
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeFI
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation
Type of Report Initial
Report Date 10/23/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/08/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date07/31/2020
Device Catalogue Number393226
Device Lot Number7207496
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/06/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/17/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/18/2017
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: 11/08/2017 Patient Sequence Number: 1
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