MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE SP S/SU 27GA 4-11/16IN WHITACRE; ANESTHESIA CONDUCTION NEEDLE

Model Number	409443
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/25/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that a needle sp s/su 27ga 4-11/16in whitacre broke at the cannula during use.The following was reported by the initial reporter: "the customer informs that a longer spinal needle was needed to take into the introducing of spinal needle through introducer due to thick subcutis of the patient.A shorter introducer ref (b)(4) (lot 2003017) was used since no longer introducer was available.Once the doctor was pulling the spinal needle out through the introducer (b)(4) the needle broke into two pieces, leaving the distal end of the needle (about 5 cms of the needle) in the soft tissue of the patients spine, about 10 cms deep in the spine.Due to this incident the knee procedure had to be done under general anaesthesia instead of the pre-planned spinal anaesthesia.At the end of the knee procedure, a spinal surgeon had to remove the 5 cm piece of spinal needle from the patients back while the patient was still under anaesthesia.Authorities have been notified by the hospital and also the patient has made an official malpractice complaint.The introducer ref (b)(4) that was used with the spinal needle ref (b)(4) was discarded and not available for investigation.The samples available for investigation are the broken spinal needle (b)(4) in two pieces and contaminated and a unused spinal needle (b)(4) from the same box and lot 0064466.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2020-12-26.Investigation summary : two samples were received by our quality team for evaluation.The first samples was the actual needle and introducer of the complaint in which hub/cannula was observed to be broken (no handle/stylet was sent).Near the breakage is observed that the cannula is bent; therefore, the incident could be verified.The other needles sent were received in closed blisters and both needles (spinal and introducer) passed visual inspection.Needles did not show angularity nor damage cannula condition.A review of the internal manufacturing device records and raw material history files for the reported lot numbers was performed and no recorded quality problems or rejections to this incident were found.Based on the investigation, the potential root cause could be due to handling issues.As per sample evidence, the sample had a notable bend on the cannula in which can be an indicative of bending and repositioning.As it is explained in the ifu, this practice may increase the risk of needle breakage and therefore it is not recommended.Also, ifu states that spinal needle and introducer should be removed together to avoid breakage and based on voc is understood that the needle was removed alone making the condition.
Event or Problem Description
It was reported that a needle sp s/su 27ga 4-11/16in whitacre broke at the cannula during use.The following was reported by the initial reporter: "the customer informs that a longer spinal needle was needed to take into the introducing of spinal needle through introducer due to thick subcutis of the patient.A shorter introducer ref 405075 (lot 2003017) was used since no longer introducer was available.Once the doctor was pulling the spinal needle out through the introducer 405075, the needle broke into two pieces, leaving the distal end of the needle (about 5 cms of the needle) in the soft tissue of the patients spine, about 10 cms deep in the spine.Due to this incident the knee procedure had to be done under general anasthesia instead of the pre-planned spinal anasthesia.At the end of the knee procedure, a spinal surgeon had to remove the 5 cm piece of spinal needle from the patients back while the patient was still under anasthesia.Authorities have been notified by the hospital and also the patient has made an official malpractise complaint.The introducer ref (b)(6) that was used with the spinal needle ref (b)(6) was discarded and not available for investigation.The samples available for investigation are the broken spinal needle 409443 in two pieces and contaminated and a unused spinal needle 409443 from the smae box and lot 0064466.".

• Brand Name: NEEDLE SP S/SU 27GA 4-11/16IN WHITACRE
• Common Device Name: ANESTHESIA CONDUCTION NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 11061781
• Report Number: 2243072-2020-02123
• Device Sequence Number: 14172195
• Product Code: BSP
• UDI-Device Identifier: 30382904094431
• UDI-Public: 30382904094431
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2021

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: Health Professional
• Device Expiration Date: 02/28/2025
• Device Model Number: 409443
• Device Catalogue Number: 409443
• Device Lot Number: 0064466
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2020
• Initial Date Received by Manufacturer: 11/25/2020
• Supplement Date Received by Manufacturer: 01/08/2021
• Initial Report FDA Received Date: 12/23/2020
• Supplement Report FDA Received Date: 01/19/2021
• 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