MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 22 G X 1 IN. BD NEXIVA¿ DIFFUSICS¿ CLOSED IV CATHETER SYSTEM; INTRAVASCULAR CATHETER

Catalog Number 383692

Device Problems Difficult to Remove (1528); Use of Device Problem (1670); Device Operates Differently Than Expected (2913); Appropriate Term/Code Not Available (3191)

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

Event Date 08/30/2017

Event Type  malfunction  

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.(b)(4).

Event Description

It was reported, the 22 g x 1 in.Bd nexiva¿ diffusics¿ closed iv catheter system was difficult to operate and compromised the patient¿s cannula during use.After inserting into the patient it became difficult to separate and pull them apart.When it finally separated, the needle was out of the arm and came upward with enough force to pierce through the plastic and almost repunctured the patient¿s skin.The patient had to have a new iv inserted.There was no report of injury or medical intervention.

Manufacturer Narrative

Investigation summary: during the sample evaluation was review the following: the washer retention component was reviewed in order to confirm if a correct washer was assembled during the manufacturing process and it show the correct assembly, the adhesive amount was review in order to confirm if the cannula was bonded to the grip component and it was found bonded correctly, also the catheter adapter was review per damage component and no issues were detected, during the device component evaluation was not found the cannula separated from grip or tip shield component.Returned material showed reported defect no.Assembly, the adhesive amount was review in order to confirm if the cannula was bonded to the grip component and it was found bonded correctly, also the catheter adapter was review per damage component and not issues were detected, during the device component evaluation was not found the cannula separated from grip or tip shield component.Returned material showed reported defect? no.No sample retention for nexiva diffusics product.Batch number 7004697 was reported.Nexiva diffusics family.A complaint history check was performed and this is the 1st related complaint reported for the defect/condition on lot number 7004697.Dhr for lot number 7004697 was reviewed and no qn¿s there are related to this lot#, during the dhr review no issues for needle disengagement difficult or separate from the during our q.A technician inspection were detected.Material 383692 with lot number 7004697 was manufactured on january 2017.During dhr review it was confirm that the qa technician performed the sampling plan per cannula pull test defect and adhesive placed correctly through the all lot manufactured as correspond and no issues were recorded, additionally all functional testing and product performance meets specification criteria, accepting and releasing this lot.All relevant information during the dhr review shown that meet all established manufacturing criteria.During the manufacturing review was detected the failure mode difficult disengagement to the lot # 7214870 catalog: ns383552, the quality nonconformance was opened through notification # 200704540.Issue previously reported for associated product family during the manufacturing process.The complaint rate remains at historical levels as observed on records.No trending observed.Investigation conclusion: bd was able to duplicate the customer¿s indicated failure mode because during a manufacturing process a similar incident was detected but the defect was not evident in the testing of the returned sample.Product within specification? yes.Root cause description: we could not confirm a specific root cause for this issue since the sample or photo sent for evaluation didn¿t show the defect mentioned before, however the followings actions were implemented in the manufacturing process in order to prevent this failure mode occurrence during the process assembly, it was documented thought the (b)(4).Rationale: no capa was opened for this issue however this issue was addressed in a quality notification 200704540 in order to prevent this failure mode into de the manufacturing process.

• Brand Name: 22 G X 1 IN. BD NEXIVA¿ DIFFUSICS¿ 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
• Manufacturer (Section G): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 6907133
• MDR Text Key: 88112173
• Report Number: 9610847-2017-00085
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K161777
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: 383692
• Device Lot Number: 7004697
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/02/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other