MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD¿ PHASEAL; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	515004
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.(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 bd¿ phaseal injector does not hold at the syringe.No serious injury or medical intervention was reported.The following information was provided by the initial reporter: the injector does not hold at the syringe.When pressure is applied to the syringe, the injector rotates and falls off.It seems that's it not compatible with the syringes.The problem was with multiple spreading batches and syringe sizes.These are all bd syringes that were used.Therefore, the syringes are to be excluded as a problem.The injector stops while screwing, but not when injecting into an infusion bag.(as soon as pressure comes out of the syringe).Then he falls off the syringe.Update: it was put on correctly, turned on and as soon as pressure came out of the syringe, the injector literally leapt out.Consider that this is a customer who has been working with the injector for 13 years.So definitely no handling problem.Name of drug: endoxan, oxaliplatin, epirubicin, carboplatin fluoro uracil, gemcitabin, gamzar, alimta, keytruda.
Additional Manufacturer Narrative
H.6.Investigation: one injector attached to a syringe, along with multiple unused samples were received for investigation.Through visual inspection, the syringe was observed to only be partially attached to the threading.No defects were noted in the thread of the injector and it was possible to properly attach to the syringe.The unused samples were inspected, no molding defects were noted and they were able to connect to syringes without issue.A device history review was performed for reported lot 1807103, no deviations or non-conformances were identified during the manufacturing process that could have contributed to the reported issue.Based on the available information we are not able to identify a root cause related to the manufacturing process at this time.
Event or Problem Description
It was reported that bd¿ phaseal injector does not hold at the syringe.No serious injury or medical intervention was reported.The following information was provided by the initial reporter: the injector does not hold at the syringe.When pressure is applied to the syringe, the injector rotates and falls off.It seems that's it not compatible with the syringes.The problem was with multiple spreading batches and syringe sizes.These are all bd syringes that were used.Therefore, the syringes are to be excluded as a problem.The injector stops while screwing, but not when injecting into an infusion bag.(as soon as pressure comes out of the syringe).Then he falls off the syringe.Update: it was put on correctly, turned on and as soon as pressure came out of the syringe, the injector literally leapt out.Consider that this is a customer who has been working with the injector for 13 years.So definitely no handling problem.Name of drug: endoxan, oxaliplatin, epirubicin, carboplatin, fluoro uracil, "gemcitabine", "gemzar", alimta, keytruda.

• Brand Name: BD¿ PHASEAL
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 8493499
• Report Number: 3003152976-2019-00257
• Device Sequence Number: 16398650
• Product Code: ONB
• UDI-Device Identifier: 30382905150044
• UDI-Public: 30382905150044
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K140591
• 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
• Report Date (Section B): 04/23/2019

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 Expiration Date: 12/31/2020
• Device Catalogue Number: 515004
• Device Lot Number: 1807103
• Initial Date Received by Manufacturer: 03/22/2019
• Supplement Date Received by Manufacturer: 03/22/2019
• Initial Report FDA Received Date: 04/08/2019
• Supplement Report FDA Received Date: 04/23/2019
• 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: Other