MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) 24G X 0.56IN (0.7 X 14 MM) INSYTE; INTERVASCULAR CATHETER

Catalog Number	381311
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).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 the 24g x 0.56in (0.7 x 14 mm) insyte experienced a general safety issue with the customer stating "the catheter part that stays in the arm of the patient (newborn) is pierced and almost fully cut.".
Additional Manufacturer Narrative
Investigation summary: 1 opened sample was received.The samples are not decontaminated.The samples were subjected to visual inspection.Needle pierced through catheter was observed on actual samples.The complaint is confirmed and product is out of specification.A device history record review was performed and showed no non-conformances associated with this issue during the production of this batch.Corrective actions have been initiated to reduce the reoccurrence of this incident.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.Capa#(b)(4) had been raised to address needle pierced through catheter issue.
Event or Problem Description
It was reported that the 24g x 0.56 in (0.7 x 14 mm) insyte experienced a general safety issue with the customer stating "the catheter part that stays in the arm of the patient (newborn) is pierced and almost fully cut.".

• Brand Name: 24G X 0.56IN (0.7 X 14 MM) INSYTE
• Common Device Name: INTERVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 8392314
• Report Number: 8041187-2019-00199
• Device Sequence Number: 16217790
• 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
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2019

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: 06/30/2023
• Device Catalogue Number: 381311
• Device Lot Number: 8198135
• Initial Date Received by Manufacturer: 02/14/2019
• Supplement Date Received by Manufacturer: 02/14/2019
• Initial Report FDA Received Date: 03/05/2019
• Supplement Report FDA Received Date: 04/04/2019
• 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