MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD INSYTE¿ CATHETER

Catalog Number	381347
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.(b)(6).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that bd insyte¿ catheter opened during storage.No serious injury or medical intervention was reported.
Event or Problem Description
It was reported that bd insyte¿ catheter opened during storage.No serious injury or medical intervention was reported.
Additional Manufacturer Narrative
Investigation: one photo was received and evaluated.Open seal was observed from the blister package in the photo.However, the samples shown in the photo are belong to 22ga insyte family which is not from the reported batch.The reported batch belong to 18ga insyte family.1 actual (unused) sample was returned for investigation.The sample was not decontaminated.Opened seal was observed on the sample.There is an indication of adhesive transferred from the top web to the bottom web on the opened seal area, and thus showed that the sealing process was completed in the manufacturing facility.The complaint is confirmed and product is out of specification.There is an indication of adhesive transferred from the top web to the bottom web on the opened seal area and thus showed that the sealing process was completed in the manufacturing facility.Hence, no assignable root cause.There was a change in the top web material during jul 2017.The reported batch was produced before the material change.Device history record was reviewed and no quality notification was raised for similar nonconformance.

• Brand Name: BD INSYTE¿ CATHETER
• Common Device Name: CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 8350605
• Report Number: 8041187-2019-00160
• Device Sequence Number: 16664545
• Product Code: FOZ
• UDI-Device Identifier: 00382903813476
• UDI-Public: 00382903813476
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2019

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: Other
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: 381347
• Device Lot Number: 4351349
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2019
• Initial Date Received by Manufacturer: 02/04/2019
• Supplement Date Received by Manufacturer: 02/04/2019
• Initial Report FDA Received Date: 02/19/2019
• Supplement Report FDA Received Date: 03/21/2019
• 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