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

Catalog Number	381157
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/31/2018
Type of Reportable Event	Malfunction
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 #: 7209534, expiration date: 2022-07-31, manufacture date: 2017-09-05.Medical device lot #: 4325589, expiration date: 2019-12-31, manufacture date: 2015-01-05.A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd angiocath¿ iv catheter had sticky foreign matter.There was no report of exposure, serious injury or medical intervention.
Event or Problem Description
It was reported that the bd angiocath¿ iv catheter had sticky foreign matter.There was no report of exposure, serious injury or medical intervention.
Additional Manufacturer Narrative
Correction: due to an it issue beginning on 7/3/2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: other.Device single use?: no.Device returned to manufacture: yes.Investigation summary: as per request, returned samples from each of the reported lot numbers were examined and samples from both lot numbers exhibited clear droplets on the surface of the catheter.A small amount of this material was removed from a sample from each of the reported lot numbers and prepared for ftir spectral analysis.The spectral analysis shows that the clear droplets of material from each of the lot numbers is most likely silicone.Bd was able to confirm the customer¿s indicated failure mode.Based on dhr review for material 381157, all samples taken for visual characteristics properly met the acceptance criteria.However, the engineering team evaluated the samples and associated the reported incident to our dipping process for catheter.Material observed as foreign material is in reality silicon which is used to lubricate the catheter.Process fmea (b)(4) and process eura (b)(4) were reviewed and there are proper controls in place to detect product malfunctions.Based on investigation results to date, root cause was associated to our current process to apply silicon to the catheter (dipping process) capa 450094 has been initiated to mitigate the reported failure mode.

• Brand Name: BD ANGIOCATH¿ IV CATHETER
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales
• MDR Report Key: 7801971
• Report Number: 9610847-2018-00266
• Device Sequence Number: 1143616
• Product Code: FOZ
• UDI-Device Identifier: 30382903811572
• UDI-Public: 30382903811572
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 09/19/2018

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: 381157
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2018
• Initial Date Received by Manufacturer: 07/31/2018
• Supplement Date Received by Manufacturer: 07/31/2018
• Initial Report FDA Received Date: 08/21/2018
• Supplement Report FDA Received Date: 10/17/2018
• 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: Other