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

Catalog Number 4540A

Device Problem Break (1069)

Patient Problems Emotional Changes (1831); Pain (1994); Foreign Body In Patient (2687)

Event Date 10/01/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4) a follow up submission will be submitted post investigation or if additional information becomes available.

Event Description

Event date unknown: the female patient was having some ¿repair work¿ done after the delivery of her child in the birthing center at the hospital.Upon insertion of the 4540a syringe the needle broke inside the patient.The patient was then moved to the or for further exploration, xray and ultrasound.The broken tip was never found.The patient has had multiple return trips to the hsp for xray, ultrasound, dr visits, has continued pain, and mental trauma from this adverse event.The patient has had pain medication and antibiotics as a result as well.(b)(6) 2018: customer response: lot number is not available, procedure was not performed under ct guidance, broken needle occurred immediately after insertion, this was patient's first pudendal block, patient did indeed have exploratory surgery attempting to locate retained product.

Event Description

Event date unknown: the female patient was having some ¿repair work¿ done after the delivery of her child in the birthing center at the hospital.Upon insertion of the 4540a syringe the needle broke inside the patient.The patient was then moved to the or for further exploration, xray and ultrasound.The broken tip was never found.The patient has had multiple return trips to the hsp for xray, ultrasound, dr visits, has continued pain, and mental trauma from this adverse event.The patient has had pain medication and antibiotics as a result as well.(b)(6)2018: attached customer response: lot number is not available, procedure was not performed under ct guidance, broken needle occurred immediately after insertion, this was patients first pudendal block, patient did indeed have exploratory surgery attempting to locate retained product.

Manufacturer Narrative

Pr (b)(4) clarification of aware date received.Emdr aware date updated from (b)(6)2018 to (b)(6)2018.

Manufacturer Narrative

(b)(4).Bd quality engineering received and evaluated the returned sample from unknown lot number and determined that there had been no breakage of the needle.It only appeared to be broken because the needle was incorrectly assembled in the inverted position.The sharpened needle tip was located fully intact but hidden within the outer hub.Measurement of the needle length and inspection of the insertion end of the returned sample further support that there was no breakage.Through the investigation our qe has concluded this was an isolated assembly error and bd is taking all appropriate actions to prevent this issue from recurring.This complaint will also continue to be tracked and trended.

Event Description

Event date unknown: the female patient was having some ¿repair work¿ done after the delivery of her child in the birthing center at the hospital.Upon insertion of the 4540a syringe the needle broke inside the patient.The patient was then moved to the or for further exploration, xray and ultrasound.The broken tip was never found.The patient has had multiple return trips to the hsp for xray, ultrasound, dr visits, has continued pain, and mental trauma from this adverse event.The patient has had pain medication and antibiotics as a result as well.17dec2018: attached customer response: lot number is not available, procedure was not performed under ct guidance, broken needle occurred immediately after insertion, this was patients first pudendal block, patient did indeed have exploratory surgery attempting to locate retained product.

• Brand Name: PARACERVICAL PUD TRAY CONTROL SYRINGE
• Type of Device: PARACERVICAL NEEDLE
• Manufacturer (Section D): CAREFUSION, INC; zona franca las americas; santo domingo
• MDR Report Key: 8208684
• MDR Text Key: 131895770
• Report Number: 9680904-2018-00032
• Device Sequence Number: 1
• Product Code: HEE
• Combination Product (y/n): N
• PMA/PMN Number: PREAMENDMANT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/20/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: 4540A
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 10/23/2018
• Initial Date FDA Received: 01/02/2019
• Supplement Dates Manufacturer Received: 10/23/2018; 10/23/2018
• Supplement Dates FDA Received: 01/02/2019; 02/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention