MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) 24 G X 0.56 IN. BD INSYTE-N¿ PERIPHERAL VENOUS CATHETER; INTERVASCULAR CATHETER

Catalog Number	381311
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/21/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
"multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 7020262.Medical device expiration date: 01/31/2022.Device manufacture date: 03/12/2017.Medical device lot #: 6341140.Medical device expiration date: 11/30/2021.Device manufacture date: 01/16/2017.(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 24 g x 0.56 in.Bd insyte-n¿ peripheral venous catheter broke off inside an infant.The piece had to be surgically removed and discarded.This mdr reportable is considered a serious injury and medical intervention took place.
Additional Manufacturer Narrative
Investigation summary: 9 representative samples in closed packaging were returned for investigation.Batch 7020262, batch 6341140, batch 6341119, figure 1: representative samples.The samples were subjected to visual inspection.No abnormalities were observed on all returned samples.Batch 7020262, batch 7020262, batch 7020262, batch 7020262, batch 6341140, batch 6341140, batch 6341140, batch 6341140, batch 6341119, root cause: the root cause of the nonconformance cannot be confirmed as the returned samples showed no abnormalities.No abnormalities were observed on the returned samples during visual inspection.Device history record of packaged needle (pn) batch 7020262, catalogue number 381311 and its assembled needle (an) batch 7020297.Part number 8301323 was reviewed.No quality notification was raised for similar nonconformance during the production of this batch.Device history record of packaged needle (pn) batch 6341140, catalogue number 381311 and its assembled needle (an) batch 6323051, part number 8301323 was reviewed.No quality notification was raised for similar nonconformance during the production of this batch.Unconfirmed: bd was not able to duplicate or confirm the customer's indicated failure mode.No capa is required at this time.

• Brand Name: 24 G X 0.56 IN. BD INSYTE-N¿ PERIPHERAL VENOUS CATHETER
• Common Device Name: INTERVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 7060554
• Report Number: 8041187-2017-00169
• Device Sequence Number: 11298902
• Product Code: FOZ
• UDI-Device Identifier: 00382903813117
• UDI-Public: 00382903813117
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2017

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 Catalogue Number: 381311
• Device Lot Number: SEE H.10.
• Initial Date Received by Manufacturer: 10/23/2017
• Supplement Date Received by Manufacturer: 10/23/2017
• Initial Report FDA Received Date: 11/27/2017
• Supplement Report FDA Received Date: 12/14/2017
• 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: Required Intervention