MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD ANGIOCATH¿ PLUS 18 G X 1.16 IN.; INTRAVASCULAR CATHETER

Catalog Number 382444

Device Problem Break (1069)

Patient Problems Pain (1994); Phlebitis (2004); Swelling (2091); Foreign Body In Patient (2687)

Event Date 03/28/2017

Event Type  Injury  

Manufacturer Narrative

Medical device expiration date: unknown.(b)(6).Pma / 510(k) #: there is no 510(k) for this device as it is manufactured outside the us and not sold in the us.Device manufacture date: unknown.Results: a device evaluation is anticipated, but has not yet begun.However, the customer also returned three photos for evaluation.Phlebitis was visualized in two of the three photos.A review of the device history record could not be performed as a lot number was not provided for this incident.Conclusion: a conclusion is not yet available as the evaluation is still in process.Upon completion of the investigation, a supplemental report will be filed.Udi #: (b)(4).

Event Description

It was reported that a bd angiocath¿ plus 18 g x 1.16 in.Was used for intravenous injection during a bronchoscopy.One week later, the patient complained that the injection site was swollen and painful.The patient received a ct scan of her brain, heart, and veins and a foreign body was found in one of the patient's blood vessels.It was also reported that the patient developed phlebitis because of the broken catheter.There was no report of any further medical or surgical interventions.

Manufacturer Narrative

Results: used fragments were returned for evaluation.The fragments were subjected to ftir testing.The ftir results showed that the spectrum of the fragments matched cellulose and does not match with the vialon and vialo-e material using in the catheter tubing.As previously reported, a review of the device history record could not be performed as a lot number was not provided for this incident.Conclusion: an absolute root cause for this incident cannot be determined as the ftir testing confirmed the returned fragments did not match the bd catheter tubing material.

• Brand Name: BD ANGIOCATH¿ PLUS 18 G X 1.16 IN.
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer (Section G): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 6513042
• MDR Text Key: 73407360
• Report Number: 8041187-2017-00036
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: N/A
• 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: 05/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 382444
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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): Required Intervention