MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) 20G X 1.16IN (1.1 X 30 MM) INSYTE; INTERVASCULAR CATHETER

Catalog Number	381334
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 has been reported that the 20g x 1.16in (1.1 x 30 mm) insyte has been found experiencing two occurrences of open packaging before use.The following has been provided by the initial reporter: in the locker, it was found that the plurality of indwelling needle package seals had been disengaged.
Event or Problem Description
It has been reported that the 20g x 1.16in (1.1 x 30 mm) insyte has been found experiencing two occurrences of open packaging before use.The following has been provided by the initial reporter: in the locker, it was found that the plurality of indwelling needle package seals had been disengaged.
Additional Manufacturer Narrative
H.6.Investigation: two samples were received by our quality team for investigation.Upon visual inspection it was observed that though the two samples were observed to have an opened seal, the adhesive that holds the paper to the plastic was transferred from the top to the bottom.This observation indicates that the sealing process was completed in the manufacturing facility, therefore; the reported failure cannot be verified.A device history record review found no non-conformances associated with this issue during production of this batch.Based on the quality teams investigation, the root cause of this incident cannot be determined.H3 other text : see h.10.

• Brand Name: 20G X 1.16IN (1.1 X 30 MM) INSYTE
• Common Device Name: INTERVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 9292753
• Report Number: 8041187-2019-00905
• Device Sequence Number: 11337701
• Product Code: FOZ
• UDI-Device Identifier: 30382903813347
• UDI-Public: 30382903813347
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K151698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2019

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: 09/30/2021
• Device Catalogue Number: 381334
• Device Lot Number: 6265032
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/23/2019
• Supplement Date Received by Manufacturer: 10/23/2019
• Initial Report FDA Received Date: 11/07/2019
• Supplement Report FDA Received Date: 11/13/2019
• 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