MAUDE Adverse Event Report: CAREFUSION, INC PARACERVICAL PUD TRAY CONTROL SYRINGE; SET, ANESTHESIA, PARACERVICAL

Catalog Number 4540A

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/07/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.(b)(4).

Event Description

Via email: we currently use the carefusion 4540a which i believe is part of the bd line? we like the thumb control but the plunger leaks the local all over the place.4/5 of the ones we¿ve used from this lot have leaked.14nov2019: additional information received from customer: although the patient wasn¿t injured from my understanding, the treatment was delayed while a 10ml syringe was prepped.I don¿t believe that would count but i¿m not sure what the criteria would be.I¿ve also added (b)(6), our ob nurse manager, to this email so she has record as well.

Event Description

Via email: we currently use the carefusion 4540a which i believe is part of the bd line? we like the thumb control but the plunger leaks the local all over the place.4/5 of the ones we¿ve used from this lot have leaked.14nov2019: additional information received from customer: although the patient wasn¿t injured from my understanding, the treatment was delayed while a 10ml syringe was prepped.I don¿t believe that would count but i¿m not sure what the criteria would be.I¿ve also added (b)(6), our ob nurse manager, to this email so she has record as well.

Manufacturer Narrative

(b)(6) follow up emdr for device evaluation/additional information received.A follow up emdr will be submitted if additional information becomes available.A review of the internal manufacturing device record and raw material history files for reported lot number 0001174581 was performed and no recorded quality problems or rejections related to this incident were found.It was confirmed that procedural and functional requirements needed for its release were met.Based on the available information, a probable root cause could not be identified for the reported failure mode at this time.This failure mode will be entered into the complaint tracking system and tracked & trended for future occurrences of any similar failure modes.A photo was provided of the device after initial investigation was performed.A follow up emdr will be submitted if additional information becomes available.H3 other text : see manufacturer narrative.

Manufacturer Narrative

Pr follow up emdr photo evaluation.Three photos were provided.One photo shows the components which conform the paracervical pud tray control syringe.Another photo shows the 10-cc control syringe.The last photo shows the label of the pouch, it was not possible to confirm the lot number reported in the photo provided.The failure mode reported is leakage.It was not possible to confirm the failure mode reported since the photos provided do not show anything related to the failure mode reported.A review of the internal manufacturing device record and raw material history files for the reported lot number was performed and no recorded quality problems or rejections related to this incident were found.Based on the investigation results and the photos provided a probable root cause could not be identified for the reported failure mode since photos did not provide a level of detail which would enable any proper method of root cause determination and batch history record and raw materials history files review did not identify any evidence for which the customer submitted the complaint.This failure mode will be entered into the complaint tracking system and tracked & trended for future occurrences of any similar failure modes h3 other text : see manufacturer narrative.

Event Description

Via email: we currently use the carefusion 4540a which i believe is part of the bd line? we like the thumb control but the plunger leaks the local all over the place.4/5 of the ones we¿ve used from this lot have leaked.14nov2019: additional information received from customer: although the patient wasn¿t injured from my understanding, the treatment was delayed while a 10ml syringe was prepped.I don¿t believe that would count but i¿m not sure what the criteria would be.I¿ve also added (b)(6) , our ob nurse manager, to this email so she has record as well.

• Brand Name: PARACERVICAL PUD TRAY CONTROL SYRINGE
• Type of Device: SET, ANESTHESIA, PARACERVICAL
• Manufacturer (Section D): CAREFUSION, INC; zona franca las americas; santo domingo
• MDR Report Key: 9355041
• MDR Text Key: 220533258
• Report Number: 9680904-2019-00025
• Device Sequence Number: 1
• Product Code: HEE
• Combination Product (y/n): N
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2022
• Device Catalogue Number: 4540A
• Device Lot Number: 0001174581
• Initial Date Manufacturer Received: 11/07/2019
• Initial Date FDA Received: 11/21/2019
• Supplement Dates Manufacturer Received: 11/07/2019; 11/07/2019
• Supplement Dates FDA Received: 02/13/2020; 02/20/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other