MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD NEXIVA¿ CLOSED IV CATHETER SYSTEM; INTRAVASCULAR CATHETER

Catalog Number 383551

Device Problems Fail-Safe Design Failure (1222); Retraction Problem (1536)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/21/2018

Event Type  malfunction  

Manufacturer Narrative

There are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Medical device lot #: unknown.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported during use of the unspecified intravascular catheter ¿the needle was unable to retract from the catheter system, with the attempt the product came apart and entire needle was exposed leaving the rn and patient at risk of needle poke.Patient required additional iv insertion attempt due to product failure.¿ there was no report of injury or medical intervention.

Manufacturer Narrative

Investigation results: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this occurrence.Dhr for lot number 7143594 was reviewed and no qn related to this batch were documented, during the dhr review we verified the quality control plan for the operations and no issues related to defect mentioned before were detected during manufacturing operation.The material 383551 with batch number mentioned before was manufactured on june 2017.Based on dhr review it was confirmed that the qa technician performed the sampling plan according our procedures without any incidents, additionally all functional testing and product performance met specification criteria, accepting and releasing this lot.All relevant information during the dhr review shown that meet all established manufacturing criteria.Without defective sample or photo we could not determine the exact root cause of the issue.For this reason we were not able to associate the reported defect to the manufacturing process.No capa was opened since this issue could not be confirmed as manufacturing related.

Manufacturer Narrative

Date of event and date received correction.Date of event: (b)(6) 2018.Date received by manufacturer: 01/24/2018.

Manufacturer Narrative

Additional information was received for the medical device lot number(s), category number (s), manufacturing/expiration date(s), manufacturing location. the following field(s) have been updated: medical device brand name: bd nexiva¿ closed iv catheter system.Medical device manufacturer: nogales (double check with (b)(4).Medical device lot #: 7143594.Medical device cat #: 383551.Udi: (b)(4).Medical device expiration date: 05/31/2020.Manufacturing location: nogales.510k: k111366.Device manufacture date: 07/06/2017.

Manufacturer Narrative

Manufacturer narrative correction for mdr supplemental #(b)(4).

• Brand Name: BD NEXIVA¿ CLOSED IV CATHETER SYSTEM
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales NJ 07417
• MDR Report Key: 7325960
• MDR Text Key: 102113409
• Report Number: 2243072-2018-00138
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K111366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 05/31/2020
• Device Catalogue Number: 383551
• Device Lot Number: 7143594
• Date Manufacturer Received: 01/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other