MAUDE Adverse Event Report: BECTON DICKINSON BD PHASEAL¿ SECONDARY SET C61; ADMINISTRATION SET

Catalog Number	515302
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturing location for this product is (b)(4).This site is not registered with the fda.Date of event: unknown.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 1011464, medical device expiration date: 2022-08-31, device manufacture date: 2019-02-28.Medical device lot #: 1011186, medical device expiration date: 2022-04-30, device manufacture date: 2019-01-31.Medical device lot #: 1010044, medical device expiration date: 2022-28-02, device manufacture date: 2018-10-25.Medical device lot #: 1010228, medical device expiration date: 2022-03-31,.Device manufacture date: 2018-11-22.(b)(6).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that during use of the bd phaseal¿ secondary set c61 there was tube leakage at the connectors.The infusion bags containing the cytostatic solutions had to be interrupted during treatment and be discarded.Thus, the mg / ml concentration of the therapy is no longer exactly guaranteed and new cytostatic solutions have to be raised.The infusion had to be prepared again.For certain products, unfortunately, in the pharmacy was not enough in stock to re-manufacture this again, the patient had to be sent home, and invited again for therapy, f.Eg.Including new blood samples for the laboratory foreign complaint the following information was provided by the initial reporter, translated from (b)(6) to english: end of (b)(6) / (b)(6) 2019: the problem persists, there are more and more incidents.The tubing still drips out at the spike closure / beginning of tubing! in everyday business one can not work anymore.
Additional Manufacturer Narrative
Investigation: dhr review was done and no issues were reported during production of this lots.30 samples were received for this complaint.All 30 samples were tested for leakage and only one sample was leaking from lot 1011464 on spike-tube joint.Ct scan was done on leaking sample which was segregated during production.After this scan additional tests were done on spike component and concentricity of lower part of spike component caused molding deficit on one side of component.Capa# (b)(4) was initiated.
Event or Problem Description
It was reported that during use of the bd phaseal¿ secondary set c61 there was tube leakage at the connectors.The infusion bags containing the cytostatic solutions had to be interrupted during treatment and be discarded.Thus, the mg / ml concentration of the therapy is no longer exactly guaranteed and new cytostatic solutions have to be raised.The infusion had to be prepared again.For certain products, unfortunately, in the pharmacy was not enough in stock to re-manufacture this again, the patient had to be sent home, and invited again for therapy, f.Eg.Including new blood samples for the laboratory.Foreign complaint the following information was provided by the initial reporter, translated from german to english: end of (b)(6) 2019: the problem persists, there are more and more incidents.The tubing still drips out at the spike closure / beginning of tubing! in everyday business one can not work anymore.
Additional Manufacturer Narrative
H.6.Investigation: dhr review was done and no issues were reported during production of this lot.No sample received for this complaint, picture was provided.Ct scan was done on leaking sample which was segregated during production.After this scan additional tests were done on spike component and the concentricity of lower part of spike component caused molding deficit on one side of component.Capa#891423 was initiated.
Event or Problem Description
It was reported that during use of the bd phaseal¿ secondary set c61 there was tube leakage at the connectors.The infusion bags containing the cytostatic solutions had to be interrupted during treatment and be discarded.Thus, the mg / ml concentration of the therapy is no longer exactly guaranteed and new cytostatic solutions have to be raised.The infusion had to be prepared again.For certain products, unfortunately, in the pharmacy was not enough in stock to re-manufacture this again, the patient had to be sent home, and invited again for therapy, f.Eg.Including new blood samples for the laboratory foreign complaint the following information was provided by the initial reporter, translated from german to english: end of (b)(6) 2019: the problem persists, there are more and more incidents.The tubing still drips out at the spike closure / beginning of tubing! in everyday business one can not work anymore.

• Brand Name: BD PHASEAL¿ SECONDARY SET C61
• Common Device Name: ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8567019
• Report Number: 2243072-2019-00823
• Device Sequence Number: 19381107
• Product Code: FPA
• UDI-Device Identifier: 00382905153020
• UDI-Public: 382905153020
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/21/2019

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: 515302
• Device Lot Number: SEE H.10
• Initial Date Received by Manufacturer: 04/02/2019
• Supplement Date Received by Manufacturer: 04/02/2019; 04/02/2019
• Initial Report FDA Received Date: 04/30/2019
• Supplement Report FDA Received Date: 05/20/2019; 06/24/2019
• 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: Required Intervention