MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 22 G X 1.00 IN. BD NEXIVA¿ DIFFUSICS¿ CLOSED IV CATHETER SYSTEM; INTRAVASCULAR CATHETER

Catalog Number 383591

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Infiltration into Tissue (1931); Swelling (2091); Burning Sensation (2146)

Event Date 08/03/2017

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.Results: a sample was not returned for evaluation.A review of the device history record could not be performed as a lot number was not provided for this incident.In the event that new, changed, or corrected information is obtained, a supplemental report will be filed.Conclusion: without a sample, an absolute root cause for this incident cannot be determined as bd was not able to duplicate or confirm the customer¿s indicated failure mode.(b)(4).

Event Description

It was reported that during an iv contrast 325psi 5cc per second for a cta using a 22 g x 1.00 in.Bd nexiva¿ diffusics¿ closed iv catheter system, the patient stated his arm was burning.Upon examination, the majority of contrast was in the right ac area.The patient was hospitalized for 24 hours and treated with altering cool and warm compresses, arm elevation and tylenol.Upon 24-hour follow-up with the patient, it was reported the swelling decreased, pain was at a ¿0¿ and there was some residual bruising.

Manufacturer Narrative

Results: no sample or photo was returned for evaluation.No sample retention for nexiva diffusics product.Lot number / product family history: regarding complaint history check this is the 1st complaint related to defect reported with the condition of reaction (irritation/inflammation) for the lot 7082539 catalog 383591, it has been received in the nexiva diffuscis family, the sample was not received for evaluation.Dhr/bhr review dhr for lot number 7082539 was reviewed and no qn¿s there are related to this lot, during the dhr review no issue during our q.A tech sampling was detected.Material 383591 with lot number 7082539 was manufactured on march 23 2017, the area, equipment and work station were cleaning correctly according internal procedures.During dhr review it was confirmed that the line clearance was performed properly.All relevant information during the dhr review shown that meet all established manufacturing criteria.Manufacturing review during the manufacturing assembly process, each work station is cleaned and verified as part of our local procedures in order to sanitize the area and avoid possible contamination to the product.If some issue is detected during the line clearance verification the line cannot start run production until this part of process is completed.Reference to known issue: five customer complaints from different lot numbers has been reported since 2013 to date for associated product family (nexiva) to this failure mode, but none of them has been confirmed as a manufacturing related.Conclusion: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure mode.The customer complaint could was not confirmed already a return sample was not available for evaluation.Root cause: we could not confirm a specific root cause for this issue since an actual sample or photo was not available for evaluation, according this matter we could not determine if it was user or manufacturing related issue.Capa determination results: no corrective action was initiated since this issue could not be confirmed as user or manufacturing related issue.

• Brand Name: 22 G X 1.00 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: 6870735
• MDR Text Key: 86426888
• Report Number: 9610847-2017-00078
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161777
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/26/2017

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
• Device Operator: Health Professional
• Device Catalogue Number: 383591
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/23/2017
• Initial Date FDA Received: 09/15/2017
• Supplement Dates Manufacturer Received: 08/23/2017
• Supplement Dates FDA Received: 10/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization