MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER WITH INJECTION VALVE; INTRAVASCULAR CATHETER

Catalog Number 393222

Device Problems Deformation Due to Compressive Stress (2889); Device Fell (4014)

Patient Problem No Information (3190)

Event Date 04/11/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that bd venflon¿ pro safety peripheral safety iv catheter with injection valve when opening the package the white cap falls to the ground, because it is loos in the package.The entire infusion needle appears to be skewed and deformed in the packaging.Foreign complaint the following information was provided by the initial reporter, translated from (b)(6) to english: blue infusion needle! when opening the packaging, the white cap falls to the ground, because it is loose in the packaging.This is not normally the case.In addition, the entire infusion needle appears to be skewed and deformed in the packaging.

Manufacturer Narrative

Investigation: dhr was reviewed for both lots and no qn's were raised.2 photos, 2 used samples and 1 representative sample was returned for investigation.Returned photos: photo 1 shows 2 used samples.One sample was partially activated with end cap was detached.The other sample was in the unit package without top web label.Photo 2 shows one sample which was partially activated with its needle bent.Used samples: sample-1 has its end cap detached from the flow control plug (fcp).As the end cap has been detached from the fcp, end cap disassembly force test cannot be performed.The sample was subjected to visual inspection.The sample passed the acceptance criteria.No damage was observed on the end cap and fcp.No needle bent and no other abnormality was observed.Sample-2 was returned with a bent needle as shown in figure 5.As the needle is bent, it is not possible to hold the sample for end cap disassembly force test.Hence, end cap removal force test cannot be performed.The sample was subjected to visual inspection.No end cap and fcp damage was observed.Figure 5: used sample-2.Representative sample: the 1 representative sample was subjected to visual inspection and end cap disassembly force test.The representative sample passed the acceptance criteria.No abnormality was observed.The complaint is confirmed and product is out of specification.The reported condition of needle defect cannot be determined as the representative sample passed the acceptance criteria and based on the condition the returned sample of the needle bent, it is not possible to place the returned product in the unit packaging and hence the reported nonconformance could had happen out of the manufacturing facilities.

Event Description

It was reported that bd venflon¿ pro safety peripheral safety iv catheter with injection valve when opening the package the white cap falls to the ground, because it is loos in the package.The entire infusion needle appears to be skewed and deformed in the packaging.Foreign complaint the following information was provided by the initial reporter, translated from dutch to english: blue infusion needle! when opening the packaging, the white cap falls to the ground, because it is loose in the packaging.This is not normally the case.In addition, the entire infusion needle appears to be skewed and deformed in the packaging.

• Brand Name: BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER WITH INJECTION VALVE
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 8568731
• MDR Text Key: 144976701
• Report Number: 8041187-2019-00337
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 05/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/31/2021
• Device Catalogue Number: 393222
• Device Lot Number: 8338918
• Date Manufacturer Received: 04/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other