MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD INSYTE-W WINGED BL 22GA X 1.0IN; INTRAVASCULAR CATHETER

Catalog Number	381323
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported when using the bd insyte-w winged bl 22ga x 1.0in, the device experienced a damaged or open unit package where the sterility of the product is compromised.This event occurred 50 times.The following information was provided by the initial reporter.The customer stated: burn surgery, packaging degumming of insyte needle holder end.
Event or Problem Description
It was reported when using the bd insyte-w winged bl 22ga x 1.0in, the device experienced a damaged or open unit package where the sterility of the product is compromised.This event occurred 50 times.The following information was provided by the initial reporter.The customer stated: burn surgery, packaging degumming of insyte needle holder end.
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-12-03.H6: investigation summary twenty-one (21) actual samples were received by our quality team for evaluation.The samples were subjected to visual inspection to check for open / incomplete seal, and the seal width was measured.For all samples, an open seal was observed at the peel tab area, with 16 units with the product exposed and 5 units with the product not exposed.For 20 samples, an open seal was observed at the other end sealing area, with 15 units with the product exposed and 5 units with the product not exposed.For all samples, no open seal was observed at the lateral sides of the sealing area (where the perforation lines are).When fully peeled open, there was also a complete seal transfer observed on the whole circumference of the sealing area, with the seal width within specification.A review of the internal manufacturing device records and raw material history files for the reported lot number was performed and no recorded quality problems or rejections to this incident were found.There was no open/incomplete seal defect was found during routine in-process and outgoing inspections.The process parameters for the sealing process were also within specifications.A complete seal transfer was observed on the whole circumference of the sealing area, with a seal width within specification.This is an indication that the sealing process was completed at the tuas manufacturing plant, with a proper transfer of the sealing from the top web to the bottom web.This defect could occur outside of the tuas manufacturing plant.
Event or Problem Description
It was reported when using the bd insyte-w winged bl 22ga x 1.0in, the device experienced a damaged or open unit package where the sterility of the product is compromised.This event occurred 50 times.The following information was provided by the initial reporter.The customer stated: burn surgery, packaging degumming of insyte needle holder end.

• Brand Name: BD INSYTE-W WINGED BL 22GA X 1.0IN
• Common Device Name: INTRAVASCULAR 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13023471
• Report Number: 8041187-2021-01056
• Device Sequence Number: 4926430
• Product Code: FOZ
• UDI-Device Identifier: 00382903813230
• UDI-Public: 00382903813230
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K151698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: 381323
• Device Lot Number: 7080430
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2021
• Supplement Date Received by Manufacturer: 01/12/2022
• Initial Report FDA Received Date: 12/16/2021
• Supplement Report FDA Received Date: 01/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/16/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown