MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD INSYTE PERIPHERAL IV CATHETER WINGED GREY; INTRAVENOUS CATHETER

Catalog Number	381357
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 5174083; medical device expiration date: 06/30/2020; device manufacture date: 07/28/2015 ; medical device lot #: 4205157; medical device expiration date: 07/31/2019; device manufacture date: 08/22/2014.Investigation summary: our quality engineer inspected the returned unit and confirmed the reported observation.The source of the defect could not be determined.There was an indication of adhesive transferred from the top web to the bottom web on the opened seal area which was present on all the returned sample and thus, showed that the sealing process was completed in the manufacturing facility.A device history record review showed no non-conformances associated with this issue during the production of the reported batches.Customer complaint trends are evaluated on a monthly basis.If the trend of a specific type of complaint warrants a formal corrective action, resources will be assigned at that time.Investigation conclusion: 10 actual samples in opened packaging, from 3 different batches, were returned for investigation.Refer to figure 1.The details are as below: (b)(6).Batch number 5174083; batch number 4205157; batch number 4314498.Actual samples: the actual samples were subjected to visual inspection.Opened seal was observed on all the returned samples.Refer to figure 2.Batch 5174083; batch 4205157; batch 4314498; opened seal; opened seal was observed on all the returned samples.Root cause description: there is an indication of adhesive transferred from the top web to the bottom web on the opened seal area, refer to figure 3, which was present on all the returned sample and thus, showed that the sealing process was completed in manufacturing facility.Batch 5174083; batch 4205157; batch 4314498; figure 3: indication of adhesive transfer therefore, no assignable root cause can be established.Rationale: there is an indication of adhesive transferred from the top web to the bottom web on the opened seal area which was present on all the returned sample and thus, showed that the sealing process was completed in the manufacturing facility.
Event or Problem Description
It was reported that the bd insyte peripheral iv catheter winged grey product was partly detached prior to use.No reports of serious injury or medical intervention noted.

• Brand Name: BD INSYTE PERIPHERAL IV CATHETER WINGED GREY
• Common Device Name: INTRAVENOUS CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 7485417
• Report Number: 8041187-2018-00136
• Device Sequence Number: 1963946
• Product Code: FOZ
• UDI-Device Identifier: 00382903812677
• UDI-Public: 00382903812677
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K151698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 04/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Pharmacist
• Device Catalogue Number: 381357
• Device Lot Number: SEE H.10.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2018
• Initial Report FDA Received Date: 05/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other