MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD INSYTE-N¿ IV CATHETER; INTRAVASCULAR CATHETER

Catalog Number	381311
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2022
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 #: 2021235.Medical device expiration date: 31-may-2027.Device manufacture date: 20-may-2022.Medical device lot #: 2140686.Medical device expiration date: 31-jan-2027.Device manufacture date: 21-jan-2022.Device evaluated by mfr: 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 that 1 bd insyte-n¿ iv catheter each from lots 2021235 and 2140686 had issues with the needle piercing through catheter upon insertion.The following information was provided by the initial reporter, translated from french: "attempt to insert a peripheral venous line (vvp) on a new 15 day old.When checking the sliding of the trocar in the plastic case of the vvp, the trocar pierces the plastic case at the end.Also, sliding/inserting the trocar into the vvp is not easy as the plastic edge of the needle tends to hit the entrance of the vvp.Clinical consequences: loss of time, stress for staff and the surrounding family, crying of the baby, risk of damaging the vein.Precautionary measures: change of catheter".
Additional Manufacturer Narrative
The following fields were updated due to additional information: device available for eval yes, returned to manufacturer on: investigation summary our quality engineer inspected the 2 photos and 2 samples submitted for evaluation.The reported issues of needle through catheter were confirmed upon inspection and testing of the samples.Analysis of the samples showed the needle pierced through the catheter near the tip area and the cannula tip point was damaged.Bd could not confirm a manufacturing related root cause since the samples were all rejected by our in-line vision systems which serve to reject faulty products form the production line.Our investigation results show that these samples would have been automatically rejected if the failure occurred during production.There is a possibility the failure could have been caused during handling or transportation without the protection of needle cover.Since the samples were returned with detached needle cover and in open packaging a use related root cause cannot be determined.Production records were reviewed, and this batch meets our manufacturing specification requirements.
Event or Problem Description
It was reported that 1 bd insyte-n¿ iv catheter each from lots 2021235 and 2140686 had issues with the needle piercing through catheter upon insertion.The following information was provided by the initial reporter, translated from french: "attempt to insert a peripheral venous line (vvp) on a new 15 day old.When checking the sliding of the trocar in the plastic case of the vvp, the trocar pierces the plastic case at the end.Also, sliding/inserting the trocar into the vvp is not easy as the plastic edge of the needle tends to hit the entrance of the vvp.Clinical consequences: loss of time, stress for staff and the surrounding family, crying of the baby, risk of damaging the vein precautionary measures: change of catheter".

• Brand Name: BD INSYTE-N¿ IV CATHETER
• 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: 16185966
• Report Number: 8041187-2022-00812
• Device Sequence Number: 2570442
• Product Code: FOZ
• UDI-Device Identifier: 00382903813117
• UDI-Public: 00382903813117
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 02/28/2023

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 Catalogue Number: 381311
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2022
• Supplement Date Received by Manufacturer: 02/28/2023
• Initial Report FDA Received Date: 01/17/2023
• Supplement Report FDA Received Date: 03/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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