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	06/22/2018
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; medical device lot #: unknown; medical device expiration date: 07/31/2022; medical device expiration date: unknown; device manufacture date: 09/05/2017; device manufacture date: unknown.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.
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: "the device history report for lot number 7209534, 4325589, 4085371 and 3172184 were reviewed, no related abnormalities were found.Material number 381157 for lot 7209534, 4325589, 4085371 and 3172184 were manufactured on aug-31-2017, dec-19-2014, aug-05-2014 and jul-12-2013 respectively.This is the first instance of this failure mode with this lot number.According to the sampling plan applied for product performance, this lot was accepted and released, with no defects being noted during final assembly or in packaging visual inspections.A sample was provided for the purpose of aiding our quality engineer's investigation, inspection of the device found excessive silicon on the devices.The most probable root cause for this issue is related to the manufacturing process, silicon lubricant is applied to the catheter.Bd engineers have initiated corrective actions in response to this issue, and notified the appropriate personnel.Bd will continue to track and trend for this issue.
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.

• 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: 7694948
• Report Number: 9610847-2018-00224
• Device Sequence Number: 920992
• 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): 08/23/2018

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: 07/05/2018
• Initial Date Received by Manufacturer: 06/22/2018
• Supplement Date Received by Manufacturer: 06/22/2018
• Initial Report FDA Received Date: 07/17/2018
• Supplement Report FDA Received Date: 09/19/2018
• 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